Digestive Health

PARIS – Most diarrhea that leads patients to seek medical advice is actually a false alarm, said gastroenterologist Nassim Hammoudi, MD, PhD, of the Lariboisière Hospital in Paris, during France’s annual general medicine conference (JNMG 2023). He said that doctors need to understand the characteristics of chronic diarrhea and adapt its management accordingly. In his presentation, Dr. Hammoudi highlighted the clinical signs that should be considered.

Mechanisms of chronic diarrhea

Chronic diarrhea can result from different mechanisms, such as motility disorders related to accelerated intestinal transit, malabsorption, osmotic diarrhea, and secretory diarrhea, which are often interlinked. When an endoscopy is performed, it is recommended to conduct multilevel biopsies to detect microscopic colitis, which Dr. Hammoudi believes is “probably underdiagnosed.”

Diarrhea is defined as the passage of frequent stools (more than three a day), soft to liquid in consistency, and a daily weight exceeding 300 g. It is considered chronic when it persists for more than a month.
 

Identifying false diarrhea

Practitioners must first distinguish between genuine and false diarrhea, with the latter presenting in most consultations. “Thorough questioning is fundamental,” Dr. Hammoudi emphasized. It is essential to determine the daily stool count, the presence of nocturnal stools, and stool consistency. “A soft stool passed once a day is not diarrhea,” he said.

The most challenging form of false diarrhea to identify is what he called “constipated person’s diarrhea.” These patients, who are typically elderly, reside in care homes, and are bed-bound and taking morphine, have daily liquid stools but are actually constipated. “Taking antidiarrheal medications makes the situation worse,” said Dr. Hammoudi.

Another type of false diarrhea is tenesmus, in which patients feel like they have a full rectum, even though it is physiologically empty. The recurring urge to defecate results in mucus discharges that resemble diarrhea. Inflammatory rectal involvement could be the cause, necessitating a gastroenterology consultation.

Anal incontinence can also cause false diarrhea. It is more common in elderly people residing in care homes and in women in the postpartum period. This condition is difficult to manage and requires referral to a gastroenterologist.
 

Chronic diarrhea: Could cancer be the culprit?

After ruling out false diarrhea, clinicians should be vigilant for warning signs. The first question to consider, said Dr. Hammoudi, is whether the chronic diarrhea is associated with a lesion. Several criteria should prompt a colonoscopy, especially to search for colorectal cancer lesions:

• Age greater than 50 years
• Personal or family history of colorectal cancer
• Recent changes in bowel habits
• Rectal bleeding
• Nighttime stools
• Unexplained weight loss
• Iron-deficiency anemia

Obvious causes of chronic diarrhea should be prioritized in the management plan. Medications top the list, with more than 500 treatments – for example, ACE inhibitors, proton pump inhibitors (PPIs), antidiabetic drugs, colchicine, magnesium, laxatives – known to have diarrhea as a side effect.

Certain dietary habits can also exacerbate diarrhea, such as milk consumption in cases of lactose intolerance, or excessive sugar intake, which can lead to osmotic diarrhea.
 

IBS is often at play

Once these causes have been ruled out, several etiological pathways should be investigated. The first relates to motility issues, which are the most common diarrhea-related problem, said Dr. Hammoudi.

This type of diarrhea is linked to rapid intestinal transit time and is characterized by postprandial bowel movements (occurring shortly after a meal). Here, patients experience urgency and notice identifiable food debris in their stools. It tends to stop when fasting and can be treated effectively with antidiarrheals.

Irritable bowel syndrome (IBS) is the main cause of rapid intestinal transit diarrhea. It is defined as recurrent abdominal pain (at least 1 day/week) over a period of 3 months, associated with two of the following criteria: pain eases or worsens on passing feces, change in frequency of bowel movements, change in the consistency of stools.

Symptoms may come on suddenly, sometimes after taking antibiotics, and may result in misdiagnosis.

IBS medications treat the symptoms. Antispasmodics, such as trimebutine, phloroglucinol (Spasfon), or pinaverium bromide (Dicetel) are recommended, even there can be a placebo effect. The antidiarrheal medication loperamide (Imodium) can also be used. Probiotics may be beneficial, as an imbalanced intestinal microbiota is often implicated.

Dietary changes can also have a positive impact. Encouraging a diet rich in fruit and vegetables to enhance fiber intake is advised. A low FODMAP (fermentable oligosaccharides, disaccharides, monosaccharides, and polyols) diet, targeting short-chain carbohydrates, can also be tried to identify foods to avoid, although it may be challenging to stick to.

Postinfectious IBS is a frequent cause of rapid intestinal transit diarrhea. It generally follows an episode of acute infectious diarrhea. “Symptoms may come on suddenly, sometimes after taking antibiotics, and may result in misdiagnosis,” said Dr. Hammoudi. This type of IBS often resolves spontaneously within 6 months.
 

Consider the possibility of SIBO

Another cause of rapid intestinal transit diarrhea is small intestinal bacterial overgrowth (SIBO). It is difficult to distinguish between IBS and SIBO. Often, affected patients are diabetic, overweight, or have had bowel surgery.

The only way to diagnose SIBO is by conducting a breath test to measure the production of hydrogen and methane by the microbiota after ingesting sugar. However, the test is difficult to access and not fully covered by social security plans in France, said Dr. Hammoudi.

In cases of suspected SIBO and severe symptoms, a 7- to 10-day course of antibiotics can be attempted to provide relief, although a diagnosis should be confirmed before considering this option, Dr. Hammoudi said.
 

Malabsorption diarrhea

Another major cause of chronic diarrhea is malabsorption, characterized by large, fatty stools that are difficult to flush. Despite a normal diet, this type of diarrhea is associated with weight loss and nutritional deficiencies.

Its diagnosis involves measuring fat in the stools (steatorrhea) and possibly testing fecal elastase, an enzyme produced by the pancreas that is involved in digestion.

The most important causes of malabsorption diarrhea are pancreatic insufficiency, celiac disease, and Crohn’s disease. Generally, any lesion in the small intestine can lead to malabsorption-related diarrhea.

Celiac disease, or gluten intolerance, is an autoimmune condition triggered by a reaction to gluten proteins. Several antibodies can be produced in the presence of gluten proteins. Diagnosis is confirmed by positive antitransglutaminase antibodies and a duodenal biopsy through esophagogastroduodenoscopy.

The only treatment for celiac disease is a lifelong gluten-free diet. Celiac disease is increasingly diagnosed in adults, said Dr. Hammoudi, and should be considered as a possibility. This condition must be distinguished from gluten sensitivity, which can cause digestive issues, possibly leading to rapid intestinal transit diarrhea. “The only treatment for celiac disease is a lifelong gluten-free diet,” Dr. Hammoudi added.

Crohn’s disease, a type of inflammatory bowel disease, affects the entire digestive tract, particularly the terminal small intestine, which promotes malabsorption. In ulcerative colitis, another IBD affecting the rectum, any associated rectal syndrome can result in false diarrhea with stools containing blood and mucus.

Osmotic diarrhea, on the other hand, is linked to the presence of highly osmotic agents in the digestive tract. This type of diarrhea is watery and short-lived, stopping once the agents are no longer absorbed. The main culprits are lactose (in cases of lactose intolerance) and laxatives.
 

Drug-induced microscopic colitis

Secretory diarrhea is characterized by excessive secretions by the digestive tract, leading to significant potassium loss. This type of diarrhea is not related to food intake and is resistant to fasting.

Major causes of secretory diarrhea include microscopic colitis, parasitic infections, and endocrine tumors. Between 10% and 15% of patients with chronic diarrhea and apparently normal colonoscopy have microscopic colitis.

Dr. Hammoudi advised specialists seeking to determine the cause of chronic diarrhea to routinely collect multilevel bowel biopsies during colonoscopies from macroscopically normal mucosa to rule out microscopic colitis.

Microscopic colitis is mainly linked to the use of medications like PPIs and NSAIDs. These drugs can induce malabsorption-related diarrhea by damaging the intestinal wall.

In addition to discontinuing the implicated medication, the treatment for microscopic colitis includes low-dose budesonide (multiple brands). Biologics used in IBD may also be considered in cases of recurrent colitis.

Finally, exudative enteropathy can be a distinct cause of chronic diarrhea. It is characterized by albumin leakage (Waldmann’s disease) and manifests with edema, malnutrition, and significant hypoalbuminemia.

This article was translated from the Medscape French edition. A version of this article appeared on Medscape.com.

PARIS – Most diarrhea that leads patients to seek medical advice is actually a false alarm, said gastroenterologist Nassim Hammoudi, MD, PhD, of the Lariboisière Hospital in Paris, during France’s annual general medicine conference (JNMG 2023). He said that doctors need to understand the characteristics of chronic diarrhea and adapt its management accordingly. In his presentation, Dr. Hammoudi highlighted the clinical signs that should be considered.

Mechanisms of chronic diarrhea

Chronic diarrhea can result from different mechanisms, such as motility disorders related to accelerated intestinal transit, malabsorption, osmotic diarrhea, and secretory diarrhea, which are often interlinked. When an endoscopy is performed, it is recommended to conduct multilevel biopsies to detect microscopic colitis, which Dr. Hammoudi believes is “probably underdiagnosed.”

Diarrhea is defined as the passage of frequent stools (more than three a day), soft to liquid in consistency, and a daily weight exceeding 300 g. It is considered chronic when it persists for more than a month.
 

Identifying false diarrhea

Practitioners must first distinguish between genuine and false diarrhea, with the latter presenting in most consultations. “Thorough questioning is fundamental,” Dr. Hammoudi emphasized. It is essential to determine the daily stool count, the presence of nocturnal stools, and stool consistency. “A soft stool passed once a day is not diarrhea,” he said.

The most challenging form of false diarrhea to identify is what he called “constipated person’s diarrhea.” These patients, who are typically elderly, reside in care homes, and are bed-bound and taking morphine, have daily liquid stools but are actually constipated. “Taking antidiarrheal medications makes the situation worse,” said Dr. Hammoudi.

Another type of false diarrhea is tenesmus, in which patients feel like they have a full rectum, even though it is physiologically empty. The recurring urge to defecate results in mucus discharges that resemble diarrhea. Inflammatory rectal involvement could be the cause, necessitating a gastroenterology consultation.

Anal incontinence can also cause false diarrhea. It is more common in elderly people residing in care homes and in women in the postpartum period. This condition is difficult to manage and requires referral to a gastroenterologist.
 

Chronic diarrhea: Could cancer be the culprit?

After ruling out false diarrhea, clinicians should be vigilant for warning signs. The first question to consider, said Dr. Hammoudi, is whether the chronic diarrhea is associated with a lesion. Several criteria should prompt a colonoscopy, especially to search for colorectal cancer lesions:

• Age greater than 50 years
• Personal or family history of colorectal cancer
• Recent changes in bowel habits
• Rectal bleeding
• Nighttime stools
• Unexplained weight loss
• Iron-deficiency anemia

Obvious causes of chronic diarrhea should be prioritized in the management plan. Medications top the list, with more than 500 treatments – for example, ACE inhibitors, proton pump inhibitors (PPIs), antidiabetic drugs, colchicine, magnesium, laxatives – known to have diarrhea as a side effect.

Certain dietary habits can also exacerbate diarrhea, such as milk consumption in cases of lactose intolerance, or excessive sugar intake, which can lead to osmotic diarrhea.
 

IBS is often at play

Once these causes have been ruled out, several etiological pathways should be investigated. The first relates to motility issues, which are the most common diarrhea-related problem, said Dr. Hammoudi.

This type of diarrhea is linked to rapid intestinal transit time and is characterized by postprandial bowel movements (occurring shortly after a meal). Here, patients experience urgency and notice identifiable food debris in their stools. It tends to stop when fasting and can be treated effectively with antidiarrheals.

Irritable bowel syndrome (IBS) is the main cause of rapid intestinal transit diarrhea. It is defined as recurrent abdominal pain (at least 1 day/week) over a period of 3 months, associated with two of the following criteria: pain eases or worsens on passing feces, change in frequency of bowel movements, change in the consistency of stools.

Symptoms may come on suddenly, sometimes after taking antibiotics, and may result in misdiagnosis.

IBS medications treat the symptoms. Antispasmodics, such as trimebutine, phloroglucinol (Spasfon), or pinaverium bromide (Dicetel) are recommended, even there can be a placebo effect. The antidiarrheal medication loperamide (Imodium) can also be used. Probiotics may be beneficial, as an imbalanced intestinal microbiota is often implicated.

Dietary changes can also have a positive impact. Encouraging a diet rich in fruit and vegetables to enhance fiber intake is advised. A low FODMAP (fermentable oligosaccharides, disaccharides, monosaccharides, and polyols) diet, targeting short-chain carbohydrates, can also be tried to identify foods to avoid, although it may be challenging to stick to.

Postinfectious IBS is a frequent cause of rapid intestinal transit diarrhea. It generally follows an episode of acute infectious diarrhea. “Symptoms may come on suddenly, sometimes after taking antibiotics, and may result in misdiagnosis,” said Dr. Hammoudi. This type of IBS often resolves spontaneously within 6 months.
 

Consider the possibility of SIBO

Another cause of rapid intestinal transit diarrhea is small intestinal bacterial overgrowth (SIBO). It is difficult to distinguish between IBS and SIBO. Often, affected patients are diabetic, overweight, or have had bowel surgery.

The only way to diagnose SIBO is by conducting a breath test to measure the production of hydrogen and methane by the microbiota after ingesting sugar. However, the test is difficult to access and not fully covered by social security plans in France, said Dr. Hammoudi.

In cases of suspected SIBO and severe symptoms, a 7- to 10-day course of antibiotics can be attempted to provide relief, although a diagnosis should be confirmed before considering this option, Dr. Hammoudi said.
 

Malabsorption diarrhea

Another major cause of chronic diarrhea is malabsorption, characterized by large, fatty stools that are difficult to flush. Despite a normal diet, this type of diarrhea is associated with weight loss and nutritional deficiencies.

Its diagnosis involves measuring fat in the stools (steatorrhea) and possibly testing fecal elastase, an enzyme produced by the pancreas that is involved in digestion.

The most important causes of malabsorption diarrhea are pancreatic insufficiency, celiac disease, and Crohn’s disease. Generally, any lesion in the small intestine can lead to malabsorption-related diarrhea.

Celiac disease, or gluten intolerance, is an autoimmune condition triggered by a reaction to gluten proteins. Several antibodies can be produced in the presence of gluten proteins. Diagnosis is confirmed by positive antitransglutaminase antibodies and a duodenal biopsy through esophagogastroduodenoscopy.

The only treatment for celiac disease is a lifelong gluten-free diet. Celiac disease is increasingly diagnosed in adults, said Dr. Hammoudi, and should be considered as a possibility. This condition must be distinguished from gluten sensitivity, which can cause digestive issues, possibly leading to rapid intestinal transit diarrhea. “The only treatment for celiac disease is a lifelong gluten-free diet,” Dr. Hammoudi added.

Crohn’s disease, a type of inflammatory bowel disease, affects the entire digestive tract, particularly the terminal small intestine, which promotes malabsorption. In ulcerative colitis, another IBD affecting the rectum, any associated rectal syndrome can result in false diarrhea with stools containing blood and mucus.

Osmotic diarrhea, on the other hand, is linked to the presence of highly osmotic agents in the digestive tract. This type of diarrhea is watery and short-lived, stopping once the agents are no longer absorbed. The main culprits are lactose (in cases of lactose intolerance) and laxatives.
 

Drug-induced microscopic colitis

Secretory diarrhea is characterized by excessive secretions by the digestive tract, leading to significant potassium loss. This type of diarrhea is not related to food intake and is resistant to fasting.

Major causes of secretory diarrhea include microscopic colitis, parasitic infections, and endocrine tumors. Between 10% and 15% of patients with chronic diarrhea and apparently normal colonoscopy have microscopic colitis.

Dr. Hammoudi advised specialists seeking to determine the cause of chronic diarrhea to routinely collect multilevel bowel biopsies during colonoscopies from macroscopically normal mucosa to rule out microscopic colitis.

Microscopic colitis is mainly linked to the use of medications like PPIs and NSAIDs. These drugs can induce malabsorption-related diarrhea by damaging the intestinal wall.

In addition to discontinuing the implicated medication, the treatment for microscopic colitis includes low-dose budesonide (multiple brands). Biologics used in IBD may also be considered in cases of recurrent colitis.

Finally, exudative enteropathy can be a distinct cause of chronic diarrhea. It is characterized by albumin leakage (Waldmann’s disease) and manifests with edema, malnutrition, and significant hypoalbuminemia.

This article was translated from the Medscape French edition. A version of this article appeared on Medscape.com.

PARIS – Most diarrhea that leads patients to seek medical advice is actually a false alarm, said gastroenterologist Nassim Hammoudi, MD, PhD, of the Lariboisière Hospital in Paris, during France’s annual general medicine conference (JNMG 2023). He said that doctors need to understand the characteristics of chronic diarrhea and adapt its management accordingly. In his presentation, Dr. Hammoudi highlighted the clinical signs that should be considered.

Mechanisms of chronic diarrhea

Chronic diarrhea can result from different mechanisms, such as motility disorders related to accelerated intestinal transit, malabsorption, osmotic diarrhea, and secretory diarrhea, which are often interlinked. When an endoscopy is performed, it is recommended to conduct multilevel biopsies to detect microscopic colitis, which Dr. Hammoudi believes is “probably underdiagnosed.”

Diarrhea is defined as the passage of frequent stools (more than three a day), soft to liquid in consistency, and a daily weight exceeding 300 g. It is considered chronic when it persists for more than a month.
 

Identifying false diarrhea

Practitioners must first distinguish between genuine and false diarrhea, with the latter presenting in most consultations. “Thorough questioning is fundamental,” Dr. Hammoudi emphasized. It is essential to determine the daily stool count, the presence of nocturnal stools, and stool consistency. “A soft stool passed once a day is not diarrhea,” he said.

The most challenging form of false diarrhea to identify is what he called “constipated person’s diarrhea.” These patients, who are typically elderly, reside in care homes, and are bed-bound and taking morphine, have daily liquid stools but are actually constipated. “Taking antidiarrheal medications makes the situation worse,” said Dr. Hammoudi.

Another type of false diarrhea is tenesmus, in which patients feel like they have a full rectum, even though it is physiologically empty. The recurring urge to defecate results in mucus discharges that resemble diarrhea. Inflammatory rectal involvement could be the cause, necessitating a gastroenterology consultation.

Anal incontinence can also cause false diarrhea. It is more common in elderly people residing in care homes and in women in the postpartum period. This condition is difficult to manage and requires referral to a gastroenterologist.
 

Chronic diarrhea: Could cancer be the culprit?

After ruling out false diarrhea, clinicians should be vigilant for warning signs. The first question to consider, said Dr. Hammoudi, is whether the chronic diarrhea is associated with a lesion. Several criteria should prompt a colonoscopy, especially to search for colorectal cancer lesions:

• Age greater than 50 years
• Personal or family history of colorectal cancer
• Recent changes in bowel habits
• Rectal bleeding
• Nighttime stools
• Unexplained weight loss
• Iron-deficiency anemia

Obvious causes of chronic diarrhea should be prioritized in the management plan. Medications top the list, with more than 500 treatments – for example, ACE inhibitors, proton pump inhibitors (PPIs), antidiabetic drugs, colchicine, magnesium, laxatives – known to have diarrhea as a side effect.

Certain dietary habits can also exacerbate diarrhea, such as milk consumption in cases of lactose intolerance, or excessive sugar intake, which can lead to osmotic diarrhea.
 

IBS is often at play

Once these causes have been ruled out, several etiological pathways should be investigated. The first relates to motility issues, which are the most common diarrhea-related problem, said Dr. Hammoudi.

This type of diarrhea is linked to rapid intestinal transit time and is characterized by postprandial bowel movements (occurring shortly after a meal). Here, patients experience urgency and notice identifiable food debris in their stools. It tends to stop when fasting and can be treated effectively with antidiarrheals.

Irritable bowel syndrome (IBS) is the main cause of rapid intestinal transit diarrhea. It is defined as recurrent abdominal pain (at least 1 day/week) over a period of 3 months, associated with two of the following criteria: pain eases or worsens on passing feces, change in frequency of bowel movements, change in the consistency of stools.

Symptoms may come on suddenly, sometimes after taking antibiotics, and may result in misdiagnosis.

IBS medications treat the symptoms. Antispasmodics, such as trimebutine, phloroglucinol (Spasfon), or pinaverium bromide (Dicetel) are recommended, even there can be a placebo effect. The antidiarrheal medication loperamide (Imodium) can also be used. Probiotics may be beneficial, as an imbalanced intestinal microbiota is often implicated.

Dietary changes can also have a positive impact. Encouraging a diet rich in fruit and vegetables to enhance fiber intake is advised. A low FODMAP (fermentable oligosaccharides, disaccharides, monosaccharides, and polyols) diet, targeting short-chain carbohydrates, can also be tried to identify foods to avoid, although it may be challenging to stick to.

Postinfectious IBS is a frequent cause of rapid intestinal transit diarrhea. It generally follows an episode of acute infectious diarrhea. “Symptoms may come on suddenly, sometimes after taking antibiotics, and may result in misdiagnosis,” said Dr. Hammoudi. This type of IBS often resolves spontaneously within 6 months.
 

Consider the possibility of SIBO

Another cause of rapid intestinal transit diarrhea is small intestinal bacterial overgrowth (SIBO). It is difficult to distinguish between IBS and SIBO. Often, affected patients are diabetic, overweight, or have had bowel surgery.

The only way to diagnose SIBO is by conducting a breath test to measure the production of hydrogen and methane by the microbiota after ingesting sugar. However, the test is difficult to access and not fully covered by social security plans in France, said Dr. Hammoudi.

In cases of suspected SIBO and severe symptoms, a 7- to 10-day course of antibiotics can be attempted to provide relief, although a diagnosis should be confirmed before considering this option, Dr. Hammoudi said.
 

Malabsorption diarrhea

Another major cause of chronic diarrhea is malabsorption, characterized by large, fatty stools that are difficult to flush. Despite a normal diet, this type of diarrhea is associated with weight loss and nutritional deficiencies.

Its diagnosis involves measuring fat in the stools (steatorrhea) and possibly testing fecal elastase, an enzyme produced by the pancreas that is involved in digestion.

The most important causes of malabsorption diarrhea are pancreatic insufficiency, celiac disease, and Crohn’s disease. Generally, any lesion in the small intestine can lead to malabsorption-related diarrhea.

Celiac disease, or gluten intolerance, is an autoimmune condition triggered by a reaction to gluten proteins. Several antibodies can be produced in the presence of gluten proteins. Diagnosis is confirmed by positive antitransglutaminase antibodies and a duodenal biopsy through esophagogastroduodenoscopy.

The only treatment for celiac disease is a lifelong gluten-free diet. Celiac disease is increasingly diagnosed in adults, said Dr. Hammoudi, and should be considered as a possibility. This condition must be distinguished from gluten sensitivity, which can cause digestive issues, possibly leading to rapid intestinal transit diarrhea. “The only treatment for celiac disease is a lifelong gluten-free diet,” Dr. Hammoudi added.

Crohn’s disease, a type of inflammatory bowel disease, affects the entire digestive tract, particularly the terminal small intestine, which promotes malabsorption. In ulcerative colitis, another IBD affecting the rectum, any associated rectal syndrome can result in false diarrhea with stools containing blood and mucus.

Osmotic diarrhea, on the other hand, is linked to the presence of highly osmotic agents in the digestive tract. This type of diarrhea is watery and short-lived, stopping once the agents are no longer absorbed. The main culprits are lactose (in cases of lactose intolerance) and laxatives.
 

Drug-induced microscopic colitis

Secretory diarrhea is characterized by excessive secretions by the digestive tract, leading to significant potassium loss. This type of diarrhea is not related to food intake and is resistant to fasting.

Major causes of secretory diarrhea include microscopic colitis, parasitic infections, and endocrine tumors. Between 10% and 15% of patients with chronic diarrhea and apparently normal colonoscopy have microscopic colitis.

Dr. Hammoudi advised specialists seeking to determine the cause of chronic diarrhea to routinely collect multilevel bowel biopsies during colonoscopies from macroscopically normal mucosa to rule out microscopic colitis.

Microscopic colitis is mainly linked to the use of medications like PPIs and NSAIDs. These drugs can induce malabsorption-related diarrhea by damaging the intestinal wall.

In addition to discontinuing the implicated medication, the treatment for microscopic colitis includes low-dose budesonide (multiple brands). Biologics used in IBD may also be considered in cases of recurrent colitis.

Finally, exudative enteropathy can be a distinct cause of chronic diarrhea. It is characterized by albumin leakage (Waldmann’s disease) and manifests with edema, malnutrition, and significant hypoalbuminemia.

This article was translated from the Medscape French edition. A version of this article appeared on Medscape.com.

TOPLINE:

New research shows that adults who develop nonalcoholic fatty liver disease (NAFLD) before age 45 are at increased risk of developing cancer, particularly digestive system and lung cancer.

METHODOLOGY:

• Researchers conducted a prospective age- and sex-matched cohort study of 63,696 adults (mean age, 51 years; 83% men) in China. The patients were followed for a median of 10 years; 31,848 had NAFLD, and 31,848 were control participants.
• Participants were grouped on the basis of age at the time of diagnosis of new-onset NAFLD: younger than 45, 45-54, 55-64, and 65 and older.
• Multivariable Cox models were used to analyze cancer risk by age at NAFLD onset. Population-attributable fractions were calculated to quantify cancer risk associated with age at NAFLD onset.

TAKEAWAY:

• During follow-up, 2,415 participants were diagnosed with cancer.
• NAFLD onset before age 45 was associated with highest cancer risk in comparison with the risk among control persons (average hazard ratio [AHR], 1.52). Cancer risk decreased as age at NAFLD onset increased (AHR, 1.50 for the 45-54 cohort, 1.13 for the 55-64 cohort, and 0.75 for the 65-and-older cohort).
• Among adults younger than 45 at NAFLD onset, cancers were mainly digestive and lung cancers (AHR, 2.00 and 2.14, respectively).
• Close to 18% of the cancer risk among adults younger than 45 at NAFLD onset was attributed to their fatty liver disease.

IN PRACTICE:

“The increasing incidence of NAFLD among younger populations highlights the underestimation of harmful outcomes associated with this condition,” the authors wrote. “Our findings suggest that early control and intervention against NAFLD progression may be crucial to reduce the occurrence of NAFLD-related cancers and lessen the burden on public health.”

SOURCE:

The study, with first author Chenan Liu, MD, PhD, Beijing Shijitan Hospital, Capital Medical University, was published online in JAMA Network Open.

LIMITATIONS:

The study population was predominantly male, and NAFLD diagnosis relied on ultrasound rather than liver biopsy, potentially missing mild cases. The study lacked data on liver fibrosis elastography measurement and blood biomarkers. For some cancers, incidence rates were low.

DISCLOSURES:

The study was funded by a grant from the National Key Research and Development Program of China. The authors reported no conflicts of interest.

TOPLINE:

New research shows that adults who develop nonalcoholic fatty liver disease (NAFLD) before age 45 are at increased risk of developing cancer, particularly digestive system and lung cancer.

METHODOLOGY:

• Researchers conducted a prospective age- and sex-matched cohort study of 63,696 adults (mean age, 51 years; 83% men) in China. The patients were followed for a median of 10 years; 31,848 had NAFLD, and 31,848 were control participants.
• Participants were grouped on the basis of age at the time of diagnosis of new-onset NAFLD: younger than 45, 45-54, 55-64, and 65 and older.
• Multivariable Cox models were used to analyze cancer risk by age at NAFLD onset. Population-attributable fractions were calculated to quantify cancer risk associated with age at NAFLD onset.

TAKEAWAY:

• During follow-up, 2,415 participants were diagnosed with cancer.
• NAFLD onset before age 45 was associated with highest cancer risk in comparison with the risk among control persons (average hazard ratio [AHR], 1.52). Cancer risk decreased as age at NAFLD onset increased (AHR, 1.50 for the 45-54 cohort, 1.13 for the 55-64 cohort, and 0.75 for the 65-and-older cohort).
• Among adults younger than 45 at NAFLD onset, cancers were mainly digestive and lung cancers (AHR, 2.00 and 2.14, respectively).
• Close to 18% of the cancer risk among adults younger than 45 at NAFLD onset was attributed to their fatty liver disease.

IN PRACTICE:

“The increasing incidence of NAFLD among younger populations highlights the underestimation of harmful outcomes associated with this condition,” the authors wrote. “Our findings suggest that early control and intervention against NAFLD progression may be crucial to reduce the occurrence of NAFLD-related cancers and lessen the burden on public health.”

SOURCE:

The study, with first author Chenan Liu, MD, PhD, Beijing Shijitan Hospital, Capital Medical University, was published online in JAMA Network Open.

LIMITATIONS:

The study population was predominantly male, and NAFLD diagnosis relied on ultrasound rather than liver biopsy, potentially missing mild cases. The study lacked data on liver fibrosis elastography measurement and blood biomarkers. For some cancers, incidence rates were low.

DISCLOSURES:

The study was funded by a grant from the National Key Research and Development Program of China. The authors reported no conflicts of interest.

TOPLINE:

New research shows that adults who develop nonalcoholic fatty liver disease (NAFLD) before age 45 are at increased risk of developing cancer, particularly digestive system and lung cancer.

METHODOLOGY:

• Researchers conducted a prospective age- and sex-matched cohort study of 63,696 adults (mean age, 51 years; 83% men) in China. The patients were followed for a median of 10 years; 31,848 had NAFLD, and 31,848 were control participants.
• Participants were grouped on the basis of age at the time of diagnosis of new-onset NAFLD: younger than 45, 45-54, 55-64, and 65 and older.
• Multivariable Cox models were used to analyze cancer risk by age at NAFLD onset. Population-attributable fractions were calculated to quantify cancer risk associated with age at NAFLD onset.

TAKEAWAY:

• During follow-up, 2,415 participants were diagnosed with cancer.
• NAFLD onset before age 45 was associated with highest cancer risk in comparison with the risk among control persons (average hazard ratio [AHR], 1.52). Cancer risk decreased as age at NAFLD onset increased (AHR, 1.50 for the 45-54 cohort, 1.13 for the 55-64 cohort, and 0.75 for the 65-and-older cohort).
• Among adults younger than 45 at NAFLD onset, cancers were mainly digestive and lung cancers (AHR, 2.00 and 2.14, respectively).
• Close to 18% of the cancer risk among adults younger than 45 at NAFLD onset was attributed to their fatty liver disease.

IN PRACTICE:

“The increasing incidence of NAFLD among younger populations highlights the underestimation of harmful outcomes associated with this condition,” the authors wrote. “Our findings suggest that early control and intervention against NAFLD progression may be crucial to reduce the occurrence of NAFLD-related cancers and lessen the burden on public health.”

SOURCE:

The study, with first author Chenan Liu, MD, PhD, Beijing Shijitan Hospital, Capital Medical University, was published online in JAMA Network Open.

LIMITATIONS:

The study population was predominantly male, and NAFLD diagnosis relied on ultrasound rather than liver biopsy, potentially missing mild cases. The study lacked data on liver fibrosis elastography measurement and blood biomarkers. For some cancers, incidence rates were low.

DISCLOSURES:

The study was funded by a grant from the National Key Research and Development Program of China. The authors reported no conflicts of interest.

Most plant-based milks, such as almond or oat milk, have less calcium, vitamin D, and protein than what is found in cow’s milk, a cornerstone beverage for meeting nutritional needs, according to research from the University of Minnesota, Minneapolis. 

To make up for it, many plant-based milks are fortified with calcium and vitamin D, but most still lack the same level of protein found in cow’s milk, researchers found. The analysis included more than 200 plant-based milk alternatives, including those made from almonds, cashews, coconuts, flax, hazelnuts, hemp, oats, pistachios, rice, soy, and walnuts. The findings, which have not been published, were presented at the American Society for Nutrition’s annual conference in Boston.

“About half were fortified with vitamin D, two-thirds were fortified with calcium, and nearly 20% had protein levels similar to cow’s milk,” said lead study author Abigail Johnson, PhD, RD.

Dr. Johnson is the director of the University of Minnesota Nutrition Coordinating Center, which maintains a database of 19,000 foods for dietary research.

“I’m not seriously concerned about this, as it’s easy to get these nutrients from other sources, and cow’s milk certainly isn’t perfect and infallible,” Dr. Johnson said. “But if a consumer thinks plant-based milks are a one-to-one substitution for dairy, many of them are not.”

Consumers should read product labels and choose those that list calcium and vitamin D as ingredients, as well as consider adding other sources of calcium and vitamin D to their diets, Dr. Johnson said in a statement.

The research team plans to study plant-based milk alternatives further, such as how the products contain fiber, which cow’s milk does not. Nutrition experts explained that plant-based products have attractive features such as less fat, lower cholesterol, and higher fiber, in addition to being produced using more environmentally friendly methods, compared with cow’s milk.

Current U.S. dietary guidelines state that most plant-based milks don’t contribute to meeting recommended amounts of dairy nutrients, because their nutritional content is not similar to dairy milk or to fortified soy beverages. As many as 9 in 10 people in the U.S. don’t meet the current recommendations for dairy intake, the USDA says. An estimated 65% of U.S. children drink milk daily, and just 20% of adults drink dairy milk. Many dairy products contain high levels of added sugar, saturated fat, and sodium, the guidelines warn.

“Most individuals would benefit by increasing intake of dairy in fat-free or low-fat forms, whether from milk (including lactose-free milk), yogurt, and cheese, or from fortified soy beverages or soy yogurt,” the guidelines state. “Strategies to increase dairy intake include drinking fat-free or low-fat milk or a fortified soy beverage with meals or incorporating unsweetened fat-free or low-fat yogurt into breakfast or snacks.”

A version of this article first appeared on WebMD.com.

Most plant-based milks, such as almond or oat milk, have less calcium, vitamin D, and protein than what is found in cow’s milk, a cornerstone beverage for meeting nutritional needs, according to research from the University of Minnesota, Minneapolis. 

To make up for it, many plant-based milks are fortified with calcium and vitamin D, but most still lack the same level of protein found in cow’s milk, researchers found. The analysis included more than 200 plant-based milk alternatives, including those made from almonds, cashews, coconuts, flax, hazelnuts, hemp, oats, pistachios, rice, soy, and walnuts. The findings, which have not been published, were presented at the American Society for Nutrition’s annual conference in Boston.

“About half were fortified with vitamin D, two-thirds were fortified with calcium, and nearly 20% had protein levels similar to cow’s milk,” said lead study author Abigail Johnson, PhD, RD.

Dr. Johnson is the director of the University of Minnesota Nutrition Coordinating Center, which maintains a database of 19,000 foods for dietary research.

“I’m not seriously concerned about this, as it’s easy to get these nutrients from other sources, and cow’s milk certainly isn’t perfect and infallible,” Dr. Johnson said. “But if a consumer thinks plant-based milks are a one-to-one substitution for dairy, many of them are not.”

Consumers should read product labels and choose those that list calcium and vitamin D as ingredients, as well as consider adding other sources of calcium and vitamin D to their diets, Dr. Johnson said in a statement.

The research team plans to study plant-based milk alternatives further, such as how the products contain fiber, which cow’s milk does not. Nutrition experts explained that plant-based products have attractive features such as less fat, lower cholesterol, and higher fiber, in addition to being produced using more environmentally friendly methods, compared with cow’s milk.

Current U.S. dietary guidelines state that most plant-based milks don’t contribute to meeting recommended amounts of dairy nutrients, because their nutritional content is not similar to dairy milk or to fortified soy beverages. As many as 9 in 10 people in the U.S. don’t meet the current recommendations for dairy intake, the USDA says. An estimated 65% of U.S. children drink milk daily, and just 20% of adults drink dairy milk. Many dairy products contain high levels of added sugar, saturated fat, and sodium, the guidelines warn.

“Most individuals would benefit by increasing intake of dairy in fat-free or low-fat forms, whether from milk (including lactose-free milk), yogurt, and cheese, or from fortified soy beverages or soy yogurt,” the guidelines state. “Strategies to increase dairy intake include drinking fat-free or low-fat milk or a fortified soy beverage with meals or incorporating unsweetened fat-free or low-fat yogurt into breakfast or snacks.”

A version of this article first appeared on WebMD.com.

Most plant-based milks, such as almond or oat milk, have less calcium, vitamin D, and protein than what is found in cow’s milk, a cornerstone beverage for meeting nutritional needs, according to research from the University of Minnesota, Minneapolis. 

To make up for it, many plant-based milks are fortified with calcium and vitamin D, but most still lack the same level of protein found in cow’s milk, researchers found. The analysis included more than 200 plant-based milk alternatives, including those made from almonds, cashews, coconuts, flax, hazelnuts, hemp, oats, pistachios, rice, soy, and walnuts. The findings, which have not been published, were presented at the American Society for Nutrition’s annual conference in Boston.

“About half were fortified with vitamin D, two-thirds were fortified with calcium, and nearly 20% had protein levels similar to cow’s milk,” said lead study author Abigail Johnson, PhD, RD.

Dr. Johnson is the director of the University of Minnesota Nutrition Coordinating Center, which maintains a database of 19,000 foods for dietary research.

“I’m not seriously concerned about this, as it’s easy to get these nutrients from other sources, and cow’s milk certainly isn’t perfect and infallible,” Dr. Johnson said. “But if a consumer thinks plant-based milks are a one-to-one substitution for dairy, many of them are not.”

Consumers should read product labels and choose those that list calcium and vitamin D as ingredients, as well as consider adding other sources of calcium and vitamin D to their diets, Dr. Johnson said in a statement.

The research team plans to study plant-based milk alternatives further, such as how the products contain fiber, which cow’s milk does not. Nutrition experts explained that plant-based products have attractive features such as less fat, lower cholesterol, and higher fiber, in addition to being produced using more environmentally friendly methods, compared with cow’s milk.

Current U.S. dietary guidelines state that most plant-based milks don’t contribute to meeting recommended amounts of dairy nutrients, because their nutritional content is not similar to dairy milk or to fortified soy beverages. As many as 9 in 10 people in the U.S. don’t meet the current recommendations for dairy intake, the USDA says. An estimated 65% of U.S. children drink milk daily, and just 20% of adults drink dairy milk. Many dairy products contain high levels of added sugar, saturated fat, and sodium, the guidelines warn.

“Most individuals would benefit by increasing intake of dairy in fat-free or low-fat forms, whether from milk (including lactose-free milk), yogurt, and cheese, or from fortified soy beverages or soy yogurt,” the guidelines state. “Strategies to increase dairy intake include drinking fat-free or low-fat milk or a fortified soy beverage with meals or incorporating unsweetened fat-free or low-fat yogurt into breakfast or snacks.”

A version of this article first appeared on WebMD.com.

When used as an adjunctive treatment, probiotic supplements reduce symptoms in patients with major depression, results of a randomized, placebo-controlled trial suggest.
 

By the end of the 8-week pilot study, participants who had an incomplete response to antidepressants prior to taking probiotics scored better on measures of anxiety and depression versus placebo.

“This was a pilot study, designed as an initial exploration of whether improving gut health with probiotics could act as a new pathway for supporting mood and mental health,” study investigator Viktoriya Nikolova, PhD, Institute of Psychiatry, Psychology and Neuroscience at King’s College London, said in an interview.

“While very promising and exciting, our findings are only the first step, and larger trials are needed,” she noted.

The findings were published online in JAMA Psychiatry.
 

Gut-brain axis

It is estimated that up to 60% of people taking antidepressants for major depressive disorder (MDD) do not achieve full response.

With an eye on the so-called gut-brain axis as a treatment target for depression, the researchers conducted a meta-analysis of seven randomized controlled trials (RCT) in 2021 and found that probiotics appeared effective in reducing depressive symptoms when taken alongside antidepressants. The studies in this meta-analysis either reported poor adherence rates or did not investigate how well study participants tolerated probiotics.

To further investigate, Dr. Nikolova and team launched a pilot RCT by recruiting study participants from primary and secondary health care services, and  through general advertising in London. Data were collected from September 2019 to May 2022.

They included 49 adults diagnosed with MDD with an incomplete antidepressant response, indicated by a score of greater than 13 on the Hamilton Depression Rating Scale-17 (HAMD-17).

Half of the participants were randomly assigned to receive a widely available, proprietary, 14-strain blend probiotic supplement, and half received placebo. Both groups took their study drug four times per day during the 8-week trial.

At baseline, 4 weeks, and 8 weeks, investigators assessed the participants for depression with the HAMD-17, the Inventory of Depressive Symptomatology (IDS) Self-Report, and anxiety with the Hamilton Anxiety Rating Scale (HAMA).

The majority of participants (80%) were female with a mean age of 32 years. Adherence was high, with 97% of the doses taken as required, and no adverse events were reported.

Standardized effect sizes from linear mixed models demonstrated that, when compared with the placebo group, the probiotic group had more improvement in depressive symptoms according to the HAMD-17 (week 4: SES, 0.70; 95% confidence interval, 0.01-0.98) and IDS Self Report (week 8: SES, 0.64; 95% CI, 0.03-0.87).

When compared with the placebo group, the probiotic group also experienced greater improvements in anxiety symptoms according to the HAMA (week 4: SES, 0.67; 95% CI, 0-0.95; week 8: SES, 0.79; 95% CI, 0.06-1.05).

Dr. Nikolova said a large follow-up trial is planned to further confirm the results.

Nutritional psychiatrist Drew Ramsey, MD, author of Eat to Beat Depression and Anxiety and assistant clinical professor of psychiatry at Columbia University, New York, said in an interview: “This randomized clinical trial adds to the considerable evidence that food choices impact depression outcomes.”

He further noted that, “in nutritional psychiatry, we recommend eating fermented foods as they have been shown to improve microbiome diversity and decrease markers of inflammation.”

Dr. Ramsey noted that the RCT used the equivalent colony-forming unit of a “single serving of kombucha.”

“In our clinical group and our nutritional psychiatry course for clinicians, we recommend fermented foods over probiotics as this is the most sustainable, evidence-based way to improve microbiome diversity,” said Dr. Ramsey, citing recent research by Gardner and colleagues at Stanford (Calif.) University.

“This is an industry-funded trial that adds to the evidence base but should be interpreted by patients and clinicians as promoting consumption of more kefir, kimchi, and kombucha, not that patients should take probiotics,” he said.
 

A key place for probiotics in mental health

Commenting on the study, Uma Naidoo, MD, said: “As I shared throughout my first book, This is Your Brain on Food, there is a real place for the use of probiotics in mental health, including the importance of the gut-brain connection.”

Dr. Naidoo is the director of nutritional and metabolic psychiatry at Massachusetts General Hospital and of nutritional psychiatry at the MGH Academy, both in Boston.

She noted that, when a person stops using a probiotic after trying it out, the positive changes in the gut are reversed, so “remaining consistent in taking the probiotic is important if you have found it helpful for your mood.”

Dr. Naidoo added that “each person’s gut microbiome is so unique that it is likely not every human being will have the same reaction to a probiotic.”

“Eating foods with live probiotics may also benefit gut health and, therefore, mood,” she said. The same goes with eating fermented foods with live active cultures.”

The study was funded by a Medical Research Council Industrial CASE PhD Studentship with ADM Protexin (supplier of the probiotics) as the industry partner and additional support from Freya Green. Dr. Nikolova has received grants from the Medical Research Council and ADM Protexin during the conduct of the study as well as personal fees from Janssen outside the submitted work.

A version of this article first appeared on Medscape.com.

When used as an adjunctive treatment, probiotic supplements reduce symptoms in patients with major depression, results of a randomized, placebo-controlled trial suggest.
 

By the end of the 8-week pilot study, participants who had an incomplete response to antidepressants prior to taking probiotics scored better on measures of anxiety and depression versus placebo.

“This was a pilot study, designed as an initial exploration of whether improving gut health with probiotics could act as a new pathway for supporting mood and mental health,” study investigator Viktoriya Nikolova, PhD, Institute of Psychiatry, Psychology and Neuroscience at King’s College London, said in an interview.

“While very promising and exciting, our findings are only the first step, and larger trials are needed,” she noted.

The findings were published online in JAMA Psychiatry.
 

Gut-brain axis

It is estimated that up to 60% of people taking antidepressants for major depressive disorder (MDD) do not achieve full response.

With an eye on the so-called gut-brain axis as a treatment target for depression, the researchers conducted a meta-analysis of seven randomized controlled trials (RCT) in 2021 and found that probiotics appeared effective in reducing depressive symptoms when taken alongside antidepressants. The studies in this meta-analysis either reported poor adherence rates or did not investigate how well study participants tolerated probiotics.

To further investigate, Dr. Nikolova and team launched a pilot RCT by recruiting study participants from primary and secondary health care services, and  through general advertising in London. Data were collected from September 2019 to May 2022.

They included 49 adults diagnosed with MDD with an incomplete antidepressant response, indicated by a score of greater than 13 on the Hamilton Depression Rating Scale-17 (HAMD-17).

Half of the participants were randomly assigned to receive a widely available, proprietary, 14-strain blend probiotic supplement, and half received placebo. Both groups took their study drug four times per day during the 8-week trial.

At baseline, 4 weeks, and 8 weeks, investigators assessed the participants for depression with the HAMD-17, the Inventory of Depressive Symptomatology (IDS) Self-Report, and anxiety with the Hamilton Anxiety Rating Scale (HAMA).

The majority of participants (80%) were female with a mean age of 32 years. Adherence was high, with 97% of the doses taken as required, and no adverse events were reported.

Standardized effect sizes from linear mixed models demonstrated that, when compared with the placebo group, the probiotic group had more improvement in depressive symptoms according to the HAMD-17 (week 4: SES, 0.70; 95% confidence interval, 0.01-0.98) and IDS Self Report (week 8: SES, 0.64; 95% CI, 0.03-0.87).

When compared with the placebo group, the probiotic group also experienced greater improvements in anxiety symptoms according to the HAMA (week 4: SES, 0.67; 95% CI, 0-0.95; week 8: SES, 0.79; 95% CI, 0.06-1.05).

Dr. Nikolova said a large follow-up trial is planned to further confirm the results.

Nutritional psychiatrist Drew Ramsey, MD, author of Eat to Beat Depression and Anxiety and assistant clinical professor of psychiatry at Columbia University, New York, said in an interview: “This randomized clinical trial adds to the considerable evidence that food choices impact depression outcomes.”

He further noted that, “in nutritional psychiatry, we recommend eating fermented foods as they have been shown to improve microbiome diversity and decrease markers of inflammation.”

Dr. Ramsey noted that the RCT used the equivalent colony-forming unit of a “single serving of kombucha.”

“In our clinical group and our nutritional psychiatry course for clinicians, we recommend fermented foods over probiotics as this is the most sustainable, evidence-based way to improve microbiome diversity,” said Dr. Ramsey, citing recent research by Gardner and colleagues at Stanford (Calif.) University.

“This is an industry-funded trial that adds to the evidence base but should be interpreted by patients and clinicians as promoting consumption of more kefir, kimchi, and kombucha, not that patients should take probiotics,” he said.
 

A key place for probiotics in mental health

Commenting on the study, Uma Naidoo, MD, said: “As I shared throughout my first book, This is Your Brain on Food, there is a real place for the use of probiotics in mental health, including the importance of the gut-brain connection.”

Dr. Naidoo is the director of nutritional and metabolic psychiatry at Massachusetts General Hospital and of nutritional psychiatry at the MGH Academy, both in Boston.

She noted that, when a person stops using a probiotic after trying it out, the positive changes in the gut are reversed, so “remaining consistent in taking the probiotic is important if you have found it helpful for your mood.”

Dr. Naidoo added that “each person’s gut microbiome is so unique that it is likely not every human being will have the same reaction to a probiotic.”

“Eating foods with live probiotics may also benefit gut health and, therefore, mood,” she said. The same goes with eating fermented foods with live active cultures.”

The study was funded by a Medical Research Council Industrial CASE PhD Studentship with ADM Protexin (supplier of the probiotics) as the industry partner and additional support from Freya Green. Dr. Nikolova has received grants from the Medical Research Council and ADM Protexin during the conduct of the study as well as personal fees from Janssen outside the submitted work.

A version of this article first appeared on Medscape.com.

When used as an adjunctive treatment, probiotic supplements reduce symptoms in patients with major depression, results of a randomized, placebo-controlled trial suggest.
 

By the end of the 8-week pilot study, participants who had an incomplete response to antidepressants prior to taking probiotics scored better on measures of anxiety and depression versus placebo.

“This was a pilot study, designed as an initial exploration of whether improving gut health with probiotics could act as a new pathway for supporting mood and mental health,” study investigator Viktoriya Nikolova, PhD, Institute of Psychiatry, Psychology and Neuroscience at King’s College London, said in an interview.

“While very promising and exciting, our findings are only the first step, and larger trials are needed,” she noted.

The findings were published online in JAMA Psychiatry.
 

Gut-brain axis

It is estimated that up to 60% of people taking antidepressants for major depressive disorder (MDD) do not achieve full response.

With an eye on the so-called gut-brain axis as a treatment target for depression, the researchers conducted a meta-analysis of seven randomized controlled trials (RCT) in 2021 and found that probiotics appeared effective in reducing depressive symptoms when taken alongside antidepressants. The studies in this meta-analysis either reported poor adherence rates or did not investigate how well study participants tolerated probiotics.

To further investigate, Dr. Nikolova and team launched a pilot RCT by recruiting study participants from primary and secondary health care services, and  through general advertising in London. Data were collected from September 2019 to May 2022.

They included 49 adults diagnosed with MDD with an incomplete antidepressant response, indicated by a score of greater than 13 on the Hamilton Depression Rating Scale-17 (HAMD-17).

Half of the participants were randomly assigned to receive a widely available, proprietary, 14-strain blend probiotic supplement, and half received placebo. Both groups took their study drug four times per day during the 8-week trial.

At baseline, 4 weeks, and 8 weeks, investigators assessed the participants for depression with the HAMD-17, the Inventory of Depressive Symptomatology (IDS) Self-Report, and anxiety with the Hamilton Anxiety Rating Scale (HAMA).

The majority of participants (80%) were female with a mean age of 32 years. Adherence was high, with 97% of the doses taken as required, and no adverse events were reported.

Standardized effect sizes from linear mixed models demonstrated that, when compared with the placebo group, the probiotic group had more improvement in depressive symptoms according to the HAMD-17 (week 4: SES, 0.70; 95% confidence interval, 0.01-0.98) and IDS Self Report (week 8: SES, 0.64; 95% CI, 0.03-0.87).

When compared with the placebo group, the probiotic group also experienced greater improvements in anxiety symptoms according to the HAMA (week 4: SES, 0.67; 95% CI, 0-0.95; week 8: SES, 0.79; 95% CI, 0.06-1.05).

Dr. Nikolova said a large follow-up trial is planned to further confirm the results.

Nutritional psychiatrist Drew Ramsey, MD, author of Eat to Beat Depression and Anxiety and assistant clinical professor of psychiatry at Columbia University, New York, said in an interview: “This randomized clinical trial adds to the considerable evidence that food choices impact depression outcomes.”

He further noted that, “in nutritional psychiatry, we recommend eating fermented foods as they have been shown to improve microbiome diversity and decrease markers of inflammation.”

Dr. Ramsey noted that the RCT used the equivalent colony-forming unit of a “single serving of kombucha.”

“In our clinical group and our nutritional psychiatry course for clinicians, we recommend fermented foods over probiotics as this is the most sustainable, evidence-based way to improve microbiome diversity,” said Dr. Ramsey, citing recent research by Gardner and colleagues at Stanford (Calif.) University.

“This is an industry-funded trial that adds to the evidence base but should be interpreted by patients and clinicians as promoting consumption of more kefir, kimchi, and kombucha, not that patients should take probiotics,” he said.
 

A key place for probiotics in mental health

Commenting on the study, Uma Naidoo, MD, said: “As I shared throughout my first book, This is Your Brain on Food, there is a real place for the use of probiotics in mental health, including the importance of the gut-brain connection.”

Dr. Naidoo is the director of nutritional and metabolic psychiatry at Massachusetts General Hospital and of nutritional psychiatry at the MGH Academy, both in Boston.

She noted that, when a person stops using a probiotic after trying it out, the positive changes in the gut are reversed, so “remaining consistent in taking the probiotic is important if you have found it helpful for your mood.”

Dr. Naidoo added that “each person’s gut microbiome is so unique that it is likely not every human being will have the same reaction to a probiotic.”

“Eating foods with live probiotics may also benefit gut health and, therefore, mood,” she said. The same goes with eating fermented foods with live active cultures.”

The study was funded by a Medical Research Council Industrial CASE PhD Studentship with ADM Protexin (supplier of the probiotics) as the industry partner and additional support from Freya Green. Dr. Nikolova has received grants from the Medical Research Council and ADM Protexin during the conduct of the study as well as personal fees from Janssen outside the submitted work.

A version of this article first appeared on Medscape.com.

No significant differences emerged in gut microbial diversity in preterm infants who exclusively received human milk products, compared with those receiving bovine milk formula or fortifiers, a randomized controlled trial found. Nor were any differences noted in the secondary endpoint of clinical outcomes in the U.K. study, published online in JAMA Network Open.

Newcastle University

The finding was unanticipated, according to lead author Nicholas D. Embleton, MBBS, MD, a professor of neonatal medicine at Newcastle University in England. “Over the last 10 years we’ve focused particularly on the role of the microbiome to better understand causal mechanisms of necrotizing enterocolitis, or NEC,” he said in an interview. “We anticipated that an exclusive human milk diet would have measurable impacts on microbiome diversity as a potential mechanism [in] disease modulation as part of the mechanism by which exclusive human milk diets benefit preterm infants.”

Shortfalls in a mother’s own milk supply often necessitate the use of bovine formula or pasteurized human milk from donor milk banks or commercial suppliers.

The effect of an exclusive human milk diet versus one containing bovine products on vulnerable preterm infants is unclear, but some studies have shown lower rates of key neonatal morbidities, possibly mediated by the gut microbiome. In two randomized controlled trials, for example, one showed a lower rate of NEC with donated human milk while the other showed no difference.

Neither, however, was powered to detect a clinically important difference in surgical NEC.
 

Milk and the microbiome

The current study’s primary endpoint was the effect of an exclusive human milk diet on gut bacterial richness and diversity, as well as the proportions of specific microbial taxa in preterm infants from enrollment to 34 weeks’ postmenstrual age.

Conducted at four neonatal intensive care units in the United Kingdom from 2017 to 2020, the study recruited 126 infants born at less than 30 weeks’ gestation and fed exclusively with their own mother’s milk before 72 hours of age. With a median gestational age of 27 weeks and a median birth weight of just over 900 grams, the babies were randomized 1:1 either to their own mother’s milk plus a pasteurized ready-to-feed human milk product or to their mother’s milk plus a standard preterm formula (controls). Stool samples were collected to analyze intestinal microbiota.

In terms of clinical outcomes, four infants died in the standard-care control group and eight in the intervention group at a median postnatal age of 25 days and 15 days, respectively, but none died primarily of NEC. Formula and ready-to-feed human milk both represented less than 1% of all fluid intake, respectively.

Although there were no effects on overall measures of gut bacterial diversity, there were some insignificant effects on specific bacterial taxa previously associated with human milk feeding. “These findings suggest that the clinical impact of human milk-derived products is not modulated via microbiomic mechanisms,” the authors wrote.

Human milk could benefit, however, via components such as specific oligosaccharides, which act largely by modulating the growth of friendly Bifidobacteria and other species, Dr. Embleton said. “However, it’s possible these oligosaccharides might also directly interact via the gut epithelium as a signaling molecule. And, of course, there are many other components that might also act directly on the gut without changing the microbiome.”

*Commenting on the study but not involved in it, Brenda L. Poindexter, MD, MS, chief of the division of neonatology at Children’s Healthcare of Atlanta and Emory University, called it “incredibly important,” especially in the context of the claims of superiority made by the manufacturers of human-milk-based fortifiers. “These findings convincingly debunk the notion that the use of bovine-derived fortifiers increases risk of morbidities such as NEC through the mechanism of alterations in the microbiome, Dr. Poindexter said.

 “They refute that claim as there was no difference in NEC between the groups and, interestingly, no impact on the microbiome. One of the hypothesized mechanisms for those who purport that bovine fortifiers are ‘bad’ is that they alter the microbiome, which increases risk of NEC,” she said. “The only limitation is that the study was not powered to detect a difference in NEC, but it is incredibly important nonetheless.”

The current findings differ somewhat from those of a similar trial from 2022 showing lower microbial diversity and higher relative abundances of Enterobacteriaceae and lower abundances of Clostridium sensu stricto in preterm infants receiving an exclusive human milk diet. “These results highlight how nutrient fortifiers impact the microbiota of very-low-birth-weight infants during a critical developmental window,” the authors wrote.

Dr. Embleton conceded that his group’s study set the bar deliberately high to avoid finding too many differences purely due to chance, and it therefore might have missed bacterial changes present in low proportions. “Also, the technique we used, 16s rRNA, doesn’t explore the microbiome at the strain level, so there may have been changes we didn’t detect.”

He added that the study populations also had a relatively high usage of mother’s own milk and findings may differ in other populations and settings where the use of mother’s own milk is much lower. Furthermore, the differences reported by individual hospitals in the babies’ gut microbiomes were more significant than most feeding interventions.

So can mothers needing to use nonhuman supplements be reassured by the results? “It is difficult to know how parents may interpret our findings. We need more studies powered to detect differences in functional outcomes before we can draw conclusions and share those findings in a way parents can understand,” Dr. Embleton said. “At present, there is perhaps a too simplistic message that cow milk formula is ‘harmful.’ ”

Most babies exposed to cow’s milk fortifier or formula do not develop NEC, and many with NEC have only ever received their own mother’s milk or donor milk, he added. “It could be that with advances in pasteurization or other similar techniques the quality and therefore the functional benefits of human milk can be better preserved.”

More research is needed on the mechanisms of preterm feeding interventions, including donor human milk, fortifiers, and probiotics, Dr. Embleton said. “The gut microbiome in preterm infants is complex and very different from that in term infants.”

The study was sponsored by Newcastle Hospitals NHS Foundation Trust and funded by Prolacta Biosciences, which provided human milk formula and fortifier. Dr. Embleton reported financial ties to Danone Early Life Nutrition, Nestlé Nutrition Institute Lecture, Astarte Lecture, and NeoKare outside of the submitted work. Several coauthors reported similar ties to multiple private companies and various research funding bodies. Dr. Poindexter has no conflicts of interest.

*This story was updated on March 3, 2023.

No significant differences emerged in gut microbial diversity in preterm infants who exclusively received human milk products, compared with those receiving bovine milk formula or fortifiers, a randomized controlled trial found. Nor were any differences noted in the secondary endpoint of clinical outcomes in the U.K. study, published online in JAMA Network Open.

Newcastle University

The finding was unanticipated, according to lead author Nicholas D. Embleton, MBBS, MD, a professor of neonatal medicine at Newcastle University in England. “Over the last 10 years we’ve focused particularly on the role of the microbiome to better understand causal mechanisms of necrotizing enterocolitis, or NEC,” he said in an interview. “We anticipated that an exclusive human milk diet would have measurable impacts on microbiome diversity as a potential mechanism [in] disease modulation as part of the mechanism by which exclusive human milk diets benefit preterm infants.”

Shortfalls in a mother’s own milk supply often necessitate the use of bovine formula or pasteurized human milk from donor milk banks or commercial suppliers.

The effect of an exclusive human milk diet versus one containing bovine products on vulnerable preterm infants is unclear, but some studies have shown lower rates of key neonatal morbidities, possibly mediated by the gut microbiome. In two randomized controlled trials, for example, one showed a lower rate of NEC with donated human milk while the other showed no difference.

Neither, however, was powered to detect a clinically important difference in surgical NEC.
 

Milk and the microbiome

The current study’s primary endpoint was the effect of an exclusive human milk diet on gut bacterial richness and diversity, as well as the proportions of specific microbial taxa in preterm infants from enrollment to 34 weeks’ postmenstrual age.

Conducted at four neonatal intensive care units in the United Kingdom from 2017 to 2020, the study recruited 126 infants born at less than 30 weeks’ gestation and fed exclusively with their own mother’s milk before 72 hours of age. With a median gestational age of 27 weeks and a median birth weight of just over 900 grams, the babies were randomized 1:1 either to their own mother’s milk plus a pasteurized ready-to-feed human milk product or to their mother’s milk plus a standard preterm formula (controls). Stool samples were collected to analyze intestinal microbiota.

In terms of clinical outcomes, four infants died in the standard-care control group and eight in the intervention group at a median postnatal age of 25 days and 15 days, respectively, but none died primarily of NEC. Formula and ready-to-feed human milk both represented less than 1% of all fluid intake, respectively.

Although there were no effects on overall measures of gut bacterial diversity, there were some insignificant effects on specific bacterial taxa previously associated with human milk feeding. “These findings suggest that the clinical impact of human milk-derived products is not modulated via microbiomic mechanisms,” the authors wrote.

Human milk could benefit, however, via components such as specific oligosaccharides, which act largely by modulating the growth of friendly Bifidobacteria and other species, Dr. Embleton said. “However, it’s possible these oligosaccharides might also directly interact via the gut epithelium as a signaling molecule. And, of course, there are many other components that might also act directly on the gut without changing the microbiome.”

*Commenting on the study but not involved in it, Brenda L. Poindexter, MD, MS, chief of the division of neonatology at Children’s Healthcare of Atlanta and Emory University, called it “incredibly important,” especially in the context of the claims of superiority made by the manufacturers of human-milk-based fortifiers. “These findings convincingly debunk the notion that the use of bovine-derived fortifiers increases risk of morbidities such as NEC through the mechanism of alterations in the microbiome, Dr. Poindexter said.

 “They refute that claim as there was no difference in NEC between the groups and, interestingly, no impact on the microbiome. One of the hypothesized mechanisms for those who purport that bovine fortifiers are ‘bad’ is that they alter the microbiome, which increases risk of NEC,” she said. “The only limitation is that the study was not powered to detect a difference in NEC, but it is incredibly important nonetheless.”

The current findings differ somewhat from those of a similar trial from 2022 showing lower microbial diversity and higher relative abundances of Enterobacteriaceae and lower abundances of Clostridium sensu stricto in preterm infants receiving an exclusive human milk diet. “These results highlight how nutrient fortifiers impact the microbiota of very-low-birth-weight infants during a critical developmental window,” the authors wrote.

Dr. Embleton conceded that his group’s study set the bar deliberately high to avoid finding too many differences purely due to chance, and it therefore might have missed bacterial changes present in low proportions. “Also, the technique we used, 16s rRNA, doesn’t explore the microbiome at the strain level, so there may have been changes we didn’t detect.”

He added that the study populations also had a relatively high usage of mother’s own milk and findings may differ in other populations and settings where the use of mother’s own milk is much lower. Furthermore, the differences reported by individual hospitals in the babies’ gut microbiomes were more significant than most feeding interventions.

So can mothers needing to use nonhuman supplements be reassured by the results? “It is difficult to know how parents may interpret our findings. We need more studies powered to detect differences in functional outcomes before we can draw conclusions and share those findings in a way parents can understand,” Dr. Embleton said. “At present, there is perhaps a too simplistic message that cow milk formula is ‘harmful.’ ”

Most babies exposed to cow’s milk fortifier or formula do not develop NEC, and many with NEC have only ever received their own mother’s milk or donor milk, he added. “It could be that with advances in pasteurization or other similar techniques the quality and therefore the functional benefits of human milk can be better preserved.”

More research is needed on the mechanisms of preterm feeding interventions, including donor human milk, fortifiers, and probiotics, Dr. Embleton said. “The gut microbiome in preterm infants is complex and very different from that in term infants.”

The study was sponsored by Newcastle Hospitals NHS Foundation Trust and funded by Prolacta Biosciences, which provided human milk formula and fortifier. Dr. Embleton reported financial ties to Danone Early Life Nutrition, Nestlé Nutrition Institute Lecture, Astarte Lecture, and NeoKare outside of the submitted work. Several coauthors reported similar ties to multiple private companies and various research funding bodies. Dr. Poindexter has no conflicts of interest.

*This story was updated on March 3, 2023.

No significant differences emerged in gut microbial diversity in preterm infants who exclusively received human milk products, compared with those receiving bovine milk formula or fortifiers, a randomized controlled trial found. Nor were any differences noted in the secondary endpoint of clinical outcomes in the U.K. study, published online in JAMA Network Open.

Newcastle University

The finding was unanticipated, according to lead author Nicholas D. Embleton, MBBS, MD, a professor of neonatal medicine at Newcastle University in England. “Over the last 10 years we’ve focused particularly on the role of the microbiome to better understand causal mechanisms of necrotizing enterocolitis, or NEC,” he said in an interview. “We anticipated that an exclusive human milk diet would have measurable impacts on microbiome diversity as a potential mechanism [in] disease modulation as part of the mechanism by which exclusive human milk diets benefit preterm infants.”

Shortfalls in a mother’s own milk supply often necessitate the use of bovine formula or pasteurized human milk from donor milk banks or commercial suppliers.

The effect of an exclusive human milk diet versus one containing bovine products on vulnerable preterm infants is unclear, but some studies have shown lower rates of key neonatal morbidities, possibly mediated by the gut microbiome. In two randomized controlled trials, for example, one showed a lower rate of NEC with donated human milk while the other showed no difference.

Neither, however, was powered to detect a clinically important difference in surgical NEC.
 

Milk and the microbiome

The current study’s primary endpoint was the effect of an exclusive human milk diet on gut bacterial richness and diversity, as well as the proportions of specific microbial taxa in preterm infants from enrollment to 34 weeks’ postmenstrual age.

Conducted at four neonatal intensive care units in the United Kingdom from 2017 to 2020, the study recruited 126 infants born at less than 30 weeks’ gestation and fed exclusively with their own mother’s milk before 72 hours of age. With a median gestational age of 27 weeks and a median birth weight of just over 900 grams, the babies were randomized 1:1 either to their own mother’s milk plus a pasteurized ready-to-feed human milk product or to their mother’s milk plus a standard preterm formula (controls). Stool samples were collected to analyze intestinal microbiota.

In terms of clinical outcomes, four infants died in the standard-care control group and eight in the intervention group at a median postnatal age of 25 days and 15 days, respectively, but none died primarily of NEC. Formula and ready-to-feed human milk both represented less than 1% of all fluid intake, respectively.

Although there were no effects on overall measures of gut bacterial diversity, there were some insignificant effects on specific bacterial taxa previously associated with human milk feeding. “These findings suggest that the clinical impact of human milk-derived products is not modulated via microbiomic mechanisms,” the authors wrote.

Human milk could benefit, however, via components such as specific oligosaccharides, which act largely by modulating the growth of friendly Bifidobacteria and other species, Dr. Embleton said. “However, it’s possible these oligosaccharides might also directly interact via the gut epithelium as a signaling molecule. And, of course, there are many other components that might also act directly on the gut without changing the microbiome.”

*Commenting on the study but not involved in it, Brenda L. Poindexter, MD, MS, chief of the division of neonatology at Children’s Healthcare of Atlanta and Emory University, called it “incredibly important,” especially in the context of the claims of superiority made by the manufacturers of human-milk-based fortifiers. “These findings convincingly debunk the notion that the use of bovine-derived fortifiers increases risk of morbidities such as NEC through the mechanism of alterations in the microbiome, Dr. Poindexter said.

 “They refute that claim as there was no difference in NEC between the groups and, interestingly, no impact on the microbiome. One of the hypothesized mechanisms for those who purport that bovine fortifiers are ‘bad’ is that they alter the microbiome, which increases risk of NEC,” she said. “The only limitation is that the study was not powered to detect a difference in NEC, but it is incredibly important nonetheless.”

The current findings differ somewhat from those of a similar trial from 2022 showing lower microbial diversity and higher relative abundances of Enterobacteriaceae and lower abundances of Clostridium sensu stricto in preterm infants receiving an exclusive human milk diet. “These results highlight how nutrient fortifiers impact the microbiota of very-low-birth-weight infants during a critical developmental window,” the authors wrote.

Dr. Embleton conceded that his group’s study set the bar deliberately high to avoid finding too many differences purely due to chance, and it therefore might have missed bacterial changes present in low proportions. “Also, the technique we used, 16s rRNA, doesn’t explore the microbiome at the strain level, so there may have been changes we didn’t detect.”

He added that the study populations also had a relatively high usage of mother’s own milk and findings may differ in other populations and settings where the use of mother’s own milk is much lower. Furthermore, the differences reported by individual hospitals in the babies’ gut microbiomes were more significant than most feeding interventions.

So can mothers needing to use nonhuman supplements be reassured by the results? “It is difficult to know how parents may interpret our findings. We need more studies powered to detect differences in functional outcomes before we can draw conclusions and share those findings in a way parents can understand,” Dr. Embleton said. “At present, there is perhaps a too simplistic message that cow milk formula is ‘harmful.’ ”

Most babies exposed to cow’s milk fortifier or formula do not develop NEC, and many with NEC have only ever received their own mother’s milk or donor milk, he added. “It could be that with advances in pasteurization or other similar techniques the quality and therefore the functional benefits of human milk can be better preserved.”

More research is needed on the mechanisms of preterm feeding interventions, including donor human milk, fortifiers, and probiotics, Dr. Embleton said. “The gut microbiome in preterm infants is complex and very different from that in term infants.”

The study was sponsored by Newcastle Hospitals NHS Foundation Trust and funded by Prolacta Biosciences, which provided human milk formula and fortifier. Dr. Embleton reported financial ties to Danone Early Life Nutrition, Nestlé Nutrition Institute Lecture, Astarte Lecture, and NeoKare outside of the submitted work. Several coauthors reported similar ties to multiple private companies and various research funding bodies. Dr. Poindexter has no conflicts of interest.

*This story was updated on March 3, 2023.

FROM WORLD JOURNAL OF GASTROENTEROLOGY

One year after a diagnosis of celiac disease, more than one in five children present with functional gastrointestinal disorders (FGIDs) despite following a gluten-free diet (GFD). Developing FGIDs may be linked to caloric intake and percentage of food fat, but it does not change between a GFD with processed foods or a GFD with natural products.

These are the main findings of a study run jointly by the “Federico II” University of Naples and the “Luigi Vanvitelli” University of Campania, the results of which were published in the World Journal of Gastroenterology.

Unlike in previous studies, the criteria used in this study (the Rome IV criteria) allowed investigators to diagnose FGIDs even when other organic diseases, such as celiac disease or chronic inflammatory bowel disease, were present. The evidence obtained shows that adult individuals with celiac disease are at an increased risk for functional abdominal pain, even if they adhere well to a GFD. The researchers at the University of Campania wanted to determine the prevalence of FGIDs in the pediatric age group, which has been a poorly explored area.

The study authors enrolled 104 pediatric patients (aged 1-18 years) who had been diagnosed with celiac disease. The patients were randomly divided into two groups. Group A (n = 55) received a controlled GFD with processed foods (diet 1), and group B (n = 49) received a controlled GFD with > 60% natural products (diet 2). The presence of FGIDs was assessed at diagnosis (T0) and after 12 months (T1), and any potential link to the type of diet was analyzed.

The number of symptomatic children at enrollment was 30 of 55 (54.5%) in group A and 25 of 49 (51%) in group B. After 12 months, despite negative serology for celiac disease, the prevalence of FGIDs was 10/55 (18%) in group A and 8/49 (16.3%) in group B. There was no statistically significant difference between the two groups at T1. The most common disorder was functional constipation, followed by postprandial distress syndrome. At T1, the macro- and micronutrient intake was similar between the two groups, with no significant differences in nutrient analysis. However, in both groups, the prevalence of FGIDs was lower in patients who were consuming fewer calories (odds ratio [OR], 0.99; 95% confidence interval [CI], 0.99-1.00) and fat (OR, 0.33; 95% CI, 0.65-0.95). The figure was very close to being statistically significant (P = .055).

“This is the first study to show that the presence of functional GI symptoms in children with celiac disease on a GFD are possibly related to higher caloric and fat intake,” wrote the study authors. “It remains to be determined whether the risk is due to the persistence of a chronic inflammatory process or to nutritional factors. Long-term monitoring studies will assist in determining the natural history of these functional symptoms.”

The study authors reported having no relevant financial conflicts.

This article was translated from Univadis Italy and a version appeared on Medscape.com.

FROM WORLD JOURNAL OF GASTROENTEROLOGY

One year after a diagnosis of celiac disease, more than one in five children present with functional gastrointestinal disorders (FGIDs) despite following a gluten-free diet (GFD). Developing FGIDs may be linked to caloric intake and percentage of food fat, but it does not change between a GFD with processed foods or a GFD with natural products.

These are the main findings of a study run jointly by the “Federico II” University of Naples and the “Luigi Vanvitelli” University of Campania, the results of which were published in the World Journal of Gastroenterology.

Unlike in previous studies, the criteria used in this study (the Rome IV criteria) allowed investigators to diagnose FGIDs even when other organic diseases, such as celiac disease or chronic inflammatory bowel disease, were present. The evidence obtained shows that adult individuals with celiac disease are at an increased risk for functional abdominal pain, even if they adhere well to a GFD. The researchers at the University of Campania wanted to determine the prevalence of FGIDs in the pediatric age group, which has been a poorly explored area.

The study authors enrolled 104 pediatric patients (aged 1-18 years) who had been diagnosed with celiac disease. The patients were randomly divided into two groups. Group A (n = 55) received a controlled GFD with processed foods (diet 1), and group B (n = 49) received a controlled GFD with > 60% natural products (diet 2). The presence of FGIDs was assessed at diagnosis (T0) and after 12 months (T1), and any potential link to the type of diet was analyzed.

The number of symptomatic children at enrollment was 30 of 55 (54.5%) in group A and 25 of 49 (51%) in group B. After 12 months, despite negative serology for celiac disease, the prevalence of FGIDs was 10/55 (18%) in group A and 8/49 (16.3%) in group B. There was no statistically significant difference between the two groups at T1. The most common disorder was functional constipation, followed by postprandial distress syndrome. At T1, the macro- and micronutrient intake was similar between the two groups, with no significant differences in nutrient analysis. However, in both groups, the prevalence of FGIDs was lower in patients who were consuming fewer calories (odds ratio [OR], 0.99; 95% confidence interval [CI], 0.99-1.00) and fat (OR, 0.33; 95% CI, 0.65-0.95). The figure was very close to being statistically significant (P = .055).

“This is the first study to show that the presence of functional GI symptoms in children with celiac disease on a GFD are possibly related to higher caloric and fat intake,” wrote the study authors. “It remains to be determined whether the risk is due to the persistence of a chronic inflammatory process or to nutritional factors. Long-term monitoring studies will assist in determining the natural history of these functional symptoms.”

The study authors reported having no relevant financial conflicts.

This article was translated from Univadis Italy and a version appeared on Medscape.com.

FROM WORLD JOURNAL OF GASTROENTEROLOGY

One year after a diagnosis of celiac disease, more than one in five children present with functional gastrointestinal disorders (FGIDs) despite following a gluten-free diet (GFD). Developing FGIDs may be linked to caloric intake and percentage of food fat, but it does not change between a GFD with processed foods or a GFD with natural products.

These are the main findings of a study run jointly by the “Federico II” University of Naples and the “Luigi Vanvitelli” University of Campania, the results of which were published in the World Journal of Gastroenterology.

Unlike in previous studies, the criteria used in this study (the Rome IV criteria) allowed investigators to diagnose FGIDs even when other organic diseases, such as celiac disease or chronic inflammatory bowel disease, were present. The evidence obtained shows that adult individuals with celiac disease are at an increased risk for functional abdominal pain, even if they adhere well to a GFD. The researchers at the University of Campania wanted to determine the prevalence of FGIDs in the pediatric age group, which has been a poorly explored area.

The study authors enrolled 104 pediatric patients (aged 1-18 years) who had been diagnosed with celiac disease. The patients were randomly divided into two groups. Group A (n = 55) received a controlled GFD with processed foods (diet 1), and group B (n = 49) received a controlled GFD with > 60% natural products (diet 2). The presence of FGIDs was assessed at diagnosis (T0) and after 12 months (T1), and any potential link to the type of diet was analyzed.

The number of symptomatic children at enrollment was 30 of 55 (54.5%) in group A and 25 of 49 (51%) in group B. After 12 months, despite negative serology for celiac disease, the prevalence of FGIDs was 10/55 (18%) in group A and 8/49 (16.3%) in group B. There was no statistically significant difference between the two groups at T1. The most common disorder was functional constipation, followed by postprandial distress syndrome. At T1, the macro- and micronutrient intake was similar between the two groups, with no significant differences in nutrient analysis. However, in both groups, the prevalence of FGIDs was lower in patients who were consuming fewer calories (odds ratio [OR], 0.99; 95% confidence interval [CI], 0.99-1.00) and fat (OR, 0.33; 95% CI, 0.65-0.95). The figure was very close to being statistically significant (P = .055).

“This is the first study to show that the presence of functional GI symptoms in children with celiac disease on a GFD are possibly related to higher caloric and fat intake,” wrote the study authors. “It remains to be determined whether the risk is due to the persistence of a chronic inflammatory process or to nutritional factors. Long-term monitoring studies will assist in determining the natural history of these functional symptoms.”

The study authors reported having no relevant financial conflicts.

This article was translated from Univadis Italy and a version appeared on Medscape.com.

A common food dye found in candy, soft drinks, and some cereals, known as Allura Red, can lead to inflammatory bowel diseases, Crohn’s disease, and other health problems, new research shows.

Long-term ingestion of the dye disrupts gut function, causing a series of changes that lead to a higher risk of colitis, according to the research from McMaster University, Hamilton, Ont. The findings were published in Nature Communications.

The dye is also known as FD&C Red 40 and Food Red 17. It adds color and texture and is often used to attract children, according to a press release on Eurekalert.

“This study demonstrates significant harmful effects of Allura Red on gut health and identifies gut serotonin as a critical factor mediating these effects. These findings have important implications in the prevention and management of gut inflammation,” said senior author Waliul Khan, MBBS, PhD, a professor in the McMaster department of pathology and molecular medicine.

“What we have found is striking and alarming, as this common synthetic food dye is a possible dietary trigger for IBDs,” he said. “The literature suggests that the consumption of Allura Red also affects certain allergies, immune disorders, and behavioural problems in children, such as attention deficit hyperactivity disorder.”

The human diet in Western cultures, with its reliance on processed fats, red and processed meat, and low fiber, contributes to IBDs as well, Dr. Khan said.

Food dyes such as Allura Red have been used more and more in recent years. Their effect on gut health hasn’t been studied much.

A version of this article first appeared on WebMD.com.

A common food dye found in candy, soft drinks, and some cereals, known as Allura Red, can lead to inflammatory bowel diseases, Crohn’s disease, and other health problems, new research shows.

Long-term ingestion of the dye disrupts gut function, causing a series of changes that lead to a higher risk of colitis, according to the research from McMaster University, Hamilton, Ont. The findings were published in Nature Communications.

The dye is also known as FD&C Red 40 and Food Red 17. It adds color and texture and is often used to attract children, according to a press release on Eurekalert.

“This study demonstrates significant harmful effects of Allura Red on gut health and identifies gut serotonin as a critical factor mediating these effects. These findings have important implications in the prevention and management of gut inflammation,” said senior author Waliul Khan, MBBS, PhD, a professor in the McMaster department of pathology and molecular medicine.

“What we have found is striking and alarming, as this common synthetic food dye is a possible dietary trigger for IBDs,” he said. “The literature suggests that the consumption of Allura Red also affects certain allergies, immune disorders, and behavioural problems in children, such as attention deficit hyperactivity disorder.”

The human diet in Western cultures, with its reliance on processed fats, red and processed meat, and low fiber, contributes to IBDs as well, Dr. Khan said.

Food dyes such as Allura Red have been used more and more in recent years. Their effect on gut health hasn’t been studied much.

A version of this article first appeared on WebMD.com.

A common food dye found in candy, soft drinks, and some cereals, known as Allura Red, can lead to inflammatory bowel diseases, Crohn’s disease, and other health problems, new research shows.

Long-term ingestion of the dye disrupts gut function, causing a series of changes that lead to a higher risk of colitis, according to the research from McMaster University, Hamilton, Ont. The findings were published in Nature Communications.

The dye is also known as FD&C Red 40 and Food Red 17. It adds color and texture and is often used to attract children, according to a press release on Eurekalert.

“This study demonstrates significant harmful effects of Allura Red on gut health and identifies gut serotonin as a critical factor mediating these effects. These findings have important implications in the prevention and management of gut inflammation,” said senior author Waliul Khan, MBBS, PhD, a professor in the McMaster department of pathology and molecular medicine.

“What we have found is striking and alarming, as this common synthetic food dye is a possible dietary trigger for IBDs,” he said. “The literature suggests that the consumption of Allura Red also affects certain allergies, immune disorders, and behavioural problems in children, such as attention deficit hyperactivity disorder.”

The human diet in Western cultures, with its reliance on processed fats, red and processed meat, and low fiber, contributes to IBDs as well, Dr. Khan said.

Food dyes such as Allura Red have been used more and more in recent years. Their effect on gut health hasn’t been studied much.

A version of this article first appeared on WebMD.com.

Intermittent fasting (IF), defined as fasting for more than eight hours at a time, is a trend that is growing in popularity. Yet new research shows it may be linked to eating disorder (ED) behaviors.

Researchers from the University of Toronto analyzed data from more than 2700 adolescents and young adults from the Canadian Study of Adolescent Health Behaviors, and found that for women, IF was significantly associated with overeating, binge eating, vomiting, laxative use, and compulsive exercise.

IF in women was also associated with higher scores on the Eating Disorder Examination Questionnaire (EDE-Q), which was used to determine ED psychopathology.

Study investigator Kyle Ganson, PhD, assistant professor in the Factor-Inwentash Faculty of Social Work at the University of Toronto, said in an interview that evidence on the effectiveness of IF for weight loss and disease prevention is mixed, and that it’s important to understand the potential harms of IF – even if there are benefits for some.

“If anything, this study shines light on the fact that engagement in IF may be connected with problematic ED behaviors, requiring health care professionals to be very aware of this contemporary and popular dietary trend, despite proponents on social media touting the effectiveness and benefits,” he said.

The study was published online in Eating Behaviors.
 

Touted for health benefits

The practice of IF has been gaining popularity partly because of reputable medical experts touting its health benefits. Johns Hopkins Medicine, for instance, cited evidence that IF boosts working memory, improves blood pressure, enhances physical performance, and prevents obesity. Yet there has been little research on its harms.

As part of the Canadian Study of Adolescent Health Behaviors, Dr. Ganson and associates analyzed data on 2,700 adolescents and young adults aged 16-30 recruited from social media ads in November and December 2021. The sample included women, men, and transgender or gender-nonconforming individuals.

Study participants answered questions about weight perception, current weight change behavior, engagement in IF, and participation in eating disorder behaviors. They were also administered the EDE-Q, which measures eating disorder psychopathology.

In total, 47% of women (n = 1,470), 38% of men (n = 1,060), and 52% transgender or gender-nonconforming individuals (n = 225) reported engaging in IF during the past year.

Dr. Ganson and associates found that, for women, IF in the past 12 months and past 30 days were significantly associated with all eating disorder behaviors, including overeating, loss of control, binge eating, vomiting, laxative use, compulsive exercise, and fasting – as well as higher overall EDE-Q global scores.

For men, IF in the past 12 months was significantly associated with compulsive exercise, and higher overall EDE-Q global scores.

The team found that for TGNC participants, IF was positively associated with higher EDE-Q global scores.

The investigators acknowledged some limitations with the study – the method of recruiting, which involved ads placed on social media, could cause selection bias. In addition to this, data collection methods relied heavily on participants’ self-reporting, which could also be susceptible to bias.

“Certainly, there needs to be more investigation on this dietary practice,” said Dr. Ganson. “If anything, this study shines light on the fact that engagement in IF may be connected with problematic ED behaviors requiring healthcare professionals to be very aware of this contemporary and popular dietary trend – despite proponents on social media touting the effectiveness and benefits.”
 

Screening warranted

Dr. Ganson noted that additional research is needed to support the findings from his study, and to further illuminate the potential harms of IF.

Health care professionals “need to be aware of common, contemporary dietary trends that young people engage in and are commonly discussed on social media, such as IF,” he noted. In addition, he’d like to see health care professionals assess their patients for IF who are dieting and to follow-up with assessments for ED-related attitudes and behaviors.

“Additionally, there are likely bidirectional relationships between IF and ED attitudes and behaviors, so professionals should be aware the ways in which ED behaviors are masked as IF engagement,” Dr. Ganson said.
 

More research needed

Commenting on the findings, Angela Guarda, MD, professor of eating disorders at Johns Hopkins University and director of the eating disorders program at Johns Hopkins Hospital, both in Baltimore, said more research is needed on outcomes for IF.

“We lack a definitive answer. The reality is that IF may help some and harm others and is most likely not healthy for all,” she said, noting that the study results “support what many in the eating disorders field believe, namely that IF for someone who is at risk for an eating disorder is likely to be ill advised.”

She added that “continued research is needed to establish its safety, and for whom it may be a therapeutic versus an iatrogenic recommendation.”

The study was funded by the Connaught New Researcher Award. The authors reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Intermittent fasting (IF), defined as fasting for more than eight hours at a time, is a trend that is growing in popularity. Yet new research shows it may be linked to eating disorder (ED) behaviors.

Researchers from the University of Toronto analyzed data from more than 2700 adolescents and young adults from the Canadian Study of Adolescent Health Behaviors, and found that for women, IF was significantly associated with overeating, binge eating, vomiting, laxative use, and compulsive exercise.

IF in women was also associated with higher scores on the Eating Disorder Examination Questionnaire (EDE-Q), which was used to determine ED psychopathology.

Study investigator Kyle Ganson, PhD, assistant professor in the Factor-Inwentash Faculty of Social Work at the University of Toronto, said in an interview that evidence on the effectiveness of IF for weight loss and disease prevention is mixed, and that it’s important to understand the potential harms of IF – even if there are benefits for some.

“If anything, this study shines light on the fact that engagement in IF may be connected with problematic ED behaviors, requiring health care professionals to be very aware of this contemporary and popular dietary trend, despite proponents on social media touting the effectiveness and benefits,” he said.

The study was published online in Eating Behaviors.
 

Touted for health benefits

The practice of IF has been gaining popularity partly because of reputable medical experts touting its health benefits. Johns Hopkins Medicine, for instance, cited evidence that IF boosts working memory, improves blood pressure, enhances physical performance, and prevents obesity. Yet there has been little research on its harms.

As part of the Canadian Study of Adolescent Health Behaviors, Dr. Ganson and associates analyzed data on 2,700 adolescents and young adults aged 16-30 recruited from social media ads in November and December 2021. The sample included women, men, and transgender or gender-nonconforming individuals.

Study participants answered questions about weight perception, current weight change behavior, engagement in IF, and participation in eating disorder behaviors. They were also administered the EDE-Q, which measures eating disorder psychopathology.

In total, 47% of women (n = 1,470), 38% of men (n = 1,060), and 52% transgender or gender-nonconforming individuals (n = 225) reported engaging in IF during the past year.

Dr. Ganson and associates found that, for women, IF in the past 12 months and past 30 days were significantly associated with all eating disorder behaviors, including overeating, loss of control, binge eating, vomiting, laxative use, compulsive exercise, and fasting – as well as higher overall EDE-Q global scores.

For men, IF in the past 12 months was significantly associated with compulsive exercise, and higher overall EDE-Q global scores.

The team found that for TGNC participants, IF was positively associated with higher EDE-Q global scores.

The investigators acknowledged some limitations with the study – the method of recruiting, which involved ads placed on social media, could cause selection bias. In addition to this, data collection methods relied heavily on participants’ self-reporting, which could also be susceptible to bias.

“Certainly, there needs to be more investigation on this dietary practice,” said Dr. Ganson. “If anything, this study shines light on the fact that engagement in IF may be connected with problematic ED behaviors requiring healthcare professionals to be very aware of this contemporary and popular dietary trend – despite proponents on social media touting the effectiveness and benefits.”
 

Screening warranted

Dr. Ganson noted that additional research is needed to support the findings from his study, and to further illuminate the potential harms of IF.

Health care professionals “need to be aware of common, contemporary dietary trends that young people engage in and are commonly discussed on social media, such as IF,” he noted. In addition, he’d like to see health care professionals assess their patients for IF who are dieting and to follow-up with assessments for ED-related attitudes and behaviors.

“Additionally, there are likely bidirectional relationships between IF and ED attitudes and behaviors, so professionals should be aware the ways in which ED behaviors are masked as IF engagement,” Dr. Ganson said.
 

More research needed

Commenting on the findings, Angela Guarda, MD, professor of eating disorders at Johns Hopkins University and director of the eating disorders program at Johns Hopkins Hospital, both in Baltimore, said more research is needed on outcomes for IF.

“We lack a definitive answer. The reality is that IF may help some and harm others and is most likely not healthy for all,” she said, noting that the study results “support what many in the eating disorders field believe, namely that IF for someone who is at risk for an eating disorder is likely to be ill advised.”

She added that “continued research is needed to establish its safety, and for whom it may be a therapeutic versus an iatrogenic recommendation.”

The study was funded by the Connaught New Researcher Award. The authors reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Intermittent fasting (IF), defined as fasting for more than eight hours at a time, is a trend that is growing in popularity. Yet new research shows it may be linked to eating disorder (ED) behaviors.

Researchers from the University of Toronto analyzed data from more than 2700 adolescents and young adults from the Canadian Study of Adolescent Health Behaviors, and found that for women, IF was significantly associated with overeating, binge eating, vomiting, laxative use, and compulsive exercise.

IF in women was also associated with higher scores on the Eating Disorder Examination Questionnaire (EDE-Q), which was used to determine ED psychopathology.

Study investigator Kyle Ganson, PhD, assistant professor in the Factor-Inwentash Faculty of Social Work at the University of Toronto, said in an interview that evidence on the effectiveness of IF for weight loss and disease prevention is mixed, and that it’s important to understand the potential harms of IF – even if there are benefits for some.

“If anything, this study shines light on the fact that engagement in IF may be connected with problematic ED behaviors, requiring health care professionals to be very aware of this contemporary and popular dietary trend, despite proponents on social media touting the effectiveness and benefits,” he said.

The study was published online in Eating Behaviors.
 

Touted for health benefits

The practice of IF has been gaining popularity partly because of reputable medical experts touting its health benefits. Johns Hopkins Medicine, for instance, cited evidence that IF boosts working memory, improves blood pressure, enhances physical performance, and prevents obesity. Yet there has been little research on its harms.

As part of the Canadian Study of Adolescent Health Behaviors, Dr. Ganson and associates analyzed data on 2,700 adolescents and young adults aged 16-30 recruited from social media ads in November and December 2021. The sample included women, men, and transgender or gender-nonconforming individuals.

Study participants answered questions about weight perception, current weight change behavior, engagement in IF, and participation in eating disorder behaviors. They were also administered the EDE-Q, which measures eating disorder psychopathology.

In total, 47% of women (n = 1,470), 38% of men (n = 1,060), and 52% transgender or gender-nonconforming individuals (n = 225) reported engaging in IF during the past year.

Dr. Ganson and associates found that, for women, IF in the past 12 months and past 30 days were significantly associated with all eating disorder behaviors, including overeating, loss of control, binge eating, vomiting, laxative use, compulsive exercise, and fasting – as well as higher overall EDE-Q global scores.

For men, IF in the past 12 months was significantly associated with compulsive exercise, and higher overall EDE-Q global scores.

The team found that for TGNC participants, IF was positively associated with higher EDE-Q global scores.

The investigators acknowledged some limitations with the study – the method of recruiting, which involved ads placed on social media, could cause selection bias. In addition to this, data collection methods relied heavily on participants’ self-reporting, which could also be susceptible to bias.

“Certainly, there needs to be more investigation on this dietary practice,” said Dr. Ganson. “If anything, this study shines light on the fact that engagement in IF may be connected with problematic ED behaviors requiring healthcare professionals to be very aware of this contemporary and popular dietary trend – despite proponents on social media touting the effectiveness and benefits.”
 

Screening warranted

Dr. Ganson noted that additional research is needed to support the findings from his study, and to further illuminate the potential harms of IF.

Health care professionals “need to be aware of common, contemporary dietary trends that young people engage in and are commonly discussed on social media, such as IF,” he noted. In addition, he’d like to see health care professionals assess their patients for IF who are dieting and to follow-up with assessments for ED-related attitudes and behaviors.

“Additionally, there are likely bidirectional relationships between IF and ED attitudes and behaviors, so professionals should be aware the ways in which ED behaviors are masked as IF engagement,” Dr. Ganson said.
 

More research needed

Commenting on the findings, Angela Guarda, MD, professor of eating disorders at Johns Hopkins University and director of the eating disorders program at Johns Hopkins Hospital, both in Baltimore, said more research is needed on outcomes for IF.

“We lack a definitive answer. The reality is that IF may help some and harm others and is most likely not healthy for all,” she said, noting that the study results “support what many in the eating disorders field believe, namely that IF for someone who is at risk for an eating disorder is likely to be ill advised.”

She added that “continued research is needed to establish its safety, and for whom it may be a therapeutic versus an iatrogenic recommendation.”

The study was funded by the Connaught New Researcher Award. The authors reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Managing children’s cow’s milk allergy is costly to families and to health care systems, largely owing to costs of prescriptions, according to an industry-sponsored study based on data from the United Kingdom.

“This large cohort study provides novel evidence of a significant health economic burden of cow’s milk allergy in children,” Abbie L. Cawood, PhD, RNutr, MICR, head of scientific affairs at Nutricia Ltd in Trowbridge, England, and colleagues wrote in Clinical and Translational Allergy.

“Management of cow’s milk allergy necessitates the exclusion of cow’s milk protein from the diet. Whilst breastmilk remains the ideal nutrient source in infants with cow’s milk allergy, infants who are not exclusively breastfed require a hypoallergenic formula,” added Dr. Cawood, a visiting research fellow at University of Southampton, and her coauthors.

Cow’s milk allergy, an immune‐mediated response to one or more proteins in cow’s milk, is one of the most common childhood food allergies and affects 2%-5% of infants in Europe. Management involves avoiding cow’s milk protein and treating possible related gastrointestinal, skin, respiratory, and other allergic conditions, the authors explained.

In their retrospective matched cohort study, Dr. Cawood and colleagues turned to The Health Improvement Network (THIN), a Cegedim Rx proprietary database of 2.9 million anonymized active patient records. They extracted data from nearly 7,000 case records covering 5 years (2015-2020).

They examined medication prescriptions and health care professional contacts based on diagnosis read-codes and hypoallergenic formula prescriptions and compared health care costs for children with cow’s milk allergy with the costs for those without.

They matched 3,499 children aged 1 year or younger who had confirmed or suspected cow’s milk allergy with the same number of children without cow’s milk allergy. Around half of the participants were boys, and the mean observation period was 4.2 years.
 

Children with cow’s milk allergy need more, costly health care

The researchers found:

• Medications were prescribed to significantly more children with cow’s milk allergy (CMA), at a higher rate, than to those without CMA. In particular, prescriptions for antireflux medication increased by almost 500%.
• Children with CMA needed significantly more health care contacts and at a higher rate than those without CMA.
• CMA was linked with additional potential health care costs of £1381.53 per person per year. Assuming a 2.5% prevalence from the estimated 2%-5% CMA prevalence range and extrapolating to the UK infant population, CMA may have added more than £25.7 million in annual health care costs nationwide.

“Several conditions in infancy necessitate the elimination of cow milk–based formulas and require extensively hydrolyzed or amino acid formulas or, if preferred or able, exclusive breast milk,” Kara E. Coffey, MD, assistant professor of pediatrics at the University of Pittsburgh, said by email.

“This study shows that, regardless of the reason for cow milk–based avoidance, these infants require more healthcare service utilizations (clinic visits, nutritional assessments, prescriptions) than [do] their peers, which is certainly a commitment of a lot of time and money for their families to ensure their ability to grow and thrive,” added Dr. Coffey, who was not involved in the study.

Jodi A. Shroba, MSN, APRN, CPNP, the coordinator for the Food Allergy Program at Children’s Mercy Kansas City, Mo., did not find these numbers surprising.

“Children with food allergies typically have other atopic comorbidities that require more visits to primary care physicians and specialists and more prescriptions,” Ms. Shroba, who was not involved in the study, said by email.

“An intriguing statement is that the U.K. guidelines recommend the involvement of a dietitian for children with cow’s milk allergy,” she noted. “In the United States, having a dietitian involved would be a wonderful addition to care, as avoidance of cow’s milk can cause nutritional and growth deficiencies. But not all healthcare practices have those resources available.

“The higher rate of antibiotic use and the almost 500% increase of antireflux prescriptions by the children with cow’s milk allergy warrant additional research,” she added.

Nutricia Ltd. funded the study. Dr. Cawood and one coauthor are employed by Nutricia, and all other coauthors have been employees of or have other financial relationships with Nutricia. One coauthor is employed by Cegedim Rx, which was funded for this research by Nutricia. Ms. Shroba and Dr. Coffey report no conflicts of interest with the study.

A version of this article first appeared on Medscape.com.

Managing children’s cow’s milk allergy is costly to families and to health care systems, largely owing to costs of prescriptions, according to an industry-sponsored study based on data from the United Kingdom.

“This large cohort study provides novel evidence of a significant health economic burden of cow’s milk allergy in children,” Abbie L. Cawood, PhD, RNutr, MICR, head of scientific affairs at Nutricia Ltd in Trowbridge, England, and colleagues wrote in Clinical and Translational Allergy.

“Management of cow’s milk allergy necessitates the exclusion of cow’s milk protein from the diet. Whilst breastmilk remains the ideal nutrient source in infants with cow’s milk allergy, infants who are not exclusively breastfed require a hypoallergenic formula,” added Dr. Cawood, a visiting research fellow at University of Southampton, and her coauthors.

Cow’s milk allergy, an immune‐mediated response to one or more proteins in cow’s milk, is one of the most common childhood food allergies and affects 2%-5% of infants in Europe. Management involves avoiding cow’s milk protein and treating possible related gastrointestinal, skin, respiratory, and other allergic conditions, the authors explained.

In their retrospective matched cohort study, Dr. Cawood and colleagues turned to The Health Improvement Network (THIN), a Cegedim Rx proprietary database of 2.9 million anonymized active patient records. They extracted data from nearly 7,000 case records covering 5 years (2015-2020).

They examined medication prescriptions and health care professional contacts based on diagnosis read-codes and hypoallergenic formula prescriptions and compared health care costs for children with cow’s milk allergy with the costs for those without.

They matched 3,499 children aged 1 year or younger who had confirmed or suspected cow’s milk allergy with the same number of children without cow’s milk allergy. Around half of the participants were boys, and the mean observation period was 4.2 years.
 

Children with cow’s milk allergy need more, costly health care

The researchers found:

• Medications were prescribed to significantly more children with cow’s milk allergy (CMA), at a higher rate, than to those without CMA. In particular, prescriptions for antireflux medication increased by almost 500%.
• Children with CMA needed significantly more health care contacts and at a higher rate than those without CMA.
• CMA was linked with additional potential health care costs of £1381.53 per person per year. Assuming a 2.5% prevalence from the estimated 2%-5% CMA prevalence range and extrapolating to the UK infant population, CMA may have added more than £25.7 million in annual health care costs nationwide.

“Several conditions in infancy necessitate the elimination of cow milk–based formulas and require extensively hydrolyzed or amino acid formulas or, if preferred or able, exclusive breast milk,” Kara E. Coffey, MD, assistant professor of pediatrics at the University of Pittsburgh, said by email.

“This study shows that, regardless of the reason for cow milk–based avoidance, these infants require more healthcare service utilizations (clinic visits, nutritional assessments, prescriptions) than [do] their peers, which is certainly a commitment of a lot of time and money for their families to ensure their ability to grow and thrive,” added Dr. Coffey, who was not involved in the study.

Jodi A. Shroba, MSN, APRN, CPNP, the coordinator for the Food Allergy Program at Children’s Mercy Kansas City, Mo., did not find these numbers surprising.

“Children with food allergies typically have other atopic comorbidities that require more visits to primary care physicians and specialists and more prescriptions,” Ms. Shroba, who was not involved in the study, said by email.

“An intriguing statement is that the U.K. guidelines recommend the involvement of a dietitian for children with cow’s milk allergy,” she noted. “In the United States, having a dietitian involved would be a wonderful addition to care, as avoidance of cow’s milk can cause nutritional and growth deficiencies. But not all healthcare practices have those resources available.

“The higher rate of antibiotic use and the almost 500% increase of antireflux prescriptions by the children with cow’s milk allergy warrant additional research,” she added.

Nutricia Ltd. funded the study. Dr. Cawood and one coauthor are employed by Nutricia, and all other coauthors have been employees of or have other financial relationships with Nutricia. One coauthor is employed by Cegedim Rx, which was funded for this research by Nutricia. Ms. Shroba and Dr. Coffey report no conflicts of interest with the study.

A version of this article first appeared on Medscape.com.

Managing children’s cow’s milk allergy is costly to families and to health care systems, largely owing to costs of prescriptions, according to an industry-sponsored study based on data from the United Kingdom.

“This large cohort study provides novel evidence of a significant health economic burden of cow’s milk allergy in children,” Abbie L. Cawood, PhD, RNutr, MICR, head of scientific affairs at Nutricia Ltd in Trowbridge, England, and colleagues wrote in Clinical and Translational Allergy.

“Management of cow’s milk allergy necessitates the exclusion of cow’s milk protein from the diet. Whilst breastmilk remains the ideal nutrient source in infants with cow’s milk allergy, infants who are not exclusively breastfed require a hypoallergenic formula,” added Dr. Cawood, a visiting research fellow at University of Southampton, and her coauthors.

Cow’s milk allergy, an immune‐mediated response to one or more proteins in cow’s milk, is one of the most common childhood food allergies and affects 2%-5% of infants in Europe. Management involves avoiding cow’s milk protein and treating possible related gastrointestinal, skin, respiratory, and other allergic conditions, the authors explained.

In their retrospective matched cohort study, Dr. Cawood and colleagues turned to The Health Improvement Network (THIN), a Cegedim Rx proprietary database of 2.9 million anonymized active patient records. They extracted data from nearly 7,000 case records covering 5 years (2015-2020).

They examined medication prescriptions and health care professional contacts based on diagnosis read-codes and hypoallergenic formula prescriptions and compared health care costs for children with cow’s milk allergy with the costs for those without.

They matched 3,499 children aged 1 year or younger who had confirmed or suspected cow’s milk allergy with the same number of children without cow’s milk allergy. Around half of the participants were boys, and the mean observation period was 4.2 years.
 

Children with cow’s milk allergy need more, costly health care

The researchers found:

• Medications were prescribed to significantly more children with cow’s milk allergy (CMA), at a higher rate, than to those without CMA. In particular, prescriptions for antireflux medication increased by almost 500%.
• Children with CMA needed significantly more health care contacts and at a higher rate than those without CMA.
• CMA was linked with additional potential health care costs of £1381.53 per person per year. Assuming a 2.5% prevalence from the estimated 2%-5% CMA prevalence range and extrapolating to the UK infant population, CMA may have added more than £25.7 million in annual health care costs nationwide.

“Several conditions in infancy necessitate the elimination of cow milk–based formulas and require extensively hydrolyzed or amino acid formulas or, if preferred or able, exclusive breast milk,” Kara E. Coffey, MD, assistant professor of pediatrics at the University of Pittsburgh, said by email.

“This study shows that, regardless of the reason for cow milk–based avoidance, these infants require more healthcare service utilizations (clinic visits, nutritional assessments, prescriptions) than [do] their peers, which is certainly a commitment of a lot of time and money for their families to ensure their ability to grow and thrive,” added Dr. Coffey, who was not involved in the study.

Jodi A. Shroba, MSN, APRN, CPNP, the coordinator for the Food Allergy Program at Children’s Mercy Kansas City, Mo., did not find these numbers surprising.

“Children with food allergies typically have other atopic comorbidities that require more visits to primary care physicians and specialists and more prescriptions,” Ms. Shroba, who was not involved in the study, said by email.

“An intriguing statement is that the U.K. guidelines recommend the involvement of a dietitian for children with cow’s milk allergy,” she noted. “In the United States, having a dietitian involved would be a wonderful addition to care, as avoidance of cow’s milk can cause nutritional and growth deficiencies. But not all healthcare practices have those resources available.

“The higher rate of antibiotic use and the almost 500% increase of antireflux prescriptions by the children with cow’s milk allergy warrant additional research,” she added.

Nutricia Ltd. funded the study. Dr. Cawood and one coauthor are employed by Nutricia, and all other coauthors have been employees of or have other financial relationships with Nutricia. One coauthor is employed by Cegedim Rx, which was funded for this research by Nutricia. Ms. Shroba and Dr. Coffey report no conflicts of interest with the study.

A version of this article first appeared on Medscape.com.

Formulas for toddlers are a burgeoning business in the United States: Sales of the drinks more than doubled in recent years as companies convinced parents that their little ones needed the liquid boost. But many experts warn that these products, designed for children ages 1-3, fill no nutritional needs beyond what is available in a typical toddler diet, are subject to less regulation than infant formula, and are expensive.

In addition, some parents feed the toddler versions to infants even though they do not meet federal standards for infant formula and may not provide babies with adequate nutrients to sustain their growth.

Pediatricians and federal health officials say that when most children turn 1, they can begin drinking cow milk or an unsweetened plant-based milk substitute. In a 2019 “consensus” statement, the American Academy of Pediatrics and other health and nutrition organizations recommended against using toddler formulas, saying “they offer no unique nutritional value beyond what could be obtained with healthy foods; furthermore, they may contribute added sugars to the diet.” The toddler formulas often contain sweeteners and fats that add calories.

Some of the same companies that produce infant formula – including Enfamil, Gerber, and Similac – also make toddler formulas, as do some smaller, boutique brands that advertise that they have organic or other special qualities. Toddler formulas are available nearly everywhere infant formulas are sold and are marketed as providing extra nutrients to help children’s brain, immune system, and eye development, among other benefits. They are different from medical formulas prescribed for children with specific needs.

A 2020 study found that sales of toddler formula in the United States rose to $92 million in 2015 from $39 million in 2006.

Parents are often confused by the marketing for the formulas, according to a study led by Jennifer Harris, PhD, a marketing and public health researcher at the University of Connecticut, Hartford. She found that 60% of caregivers falsely believed toddler formulas have nutrients that toddlers can’t get from other foods.

Anthony Porto, MD, MPH, a pediatric gastroenterologist and pediatrics professor at Yale University, New Haven, Conn., said he is concerned these products could be giving toddlers more nutrients and calories than they need. Unlike what’s designed for infants, toddler formula has no nutritional regulations: Experts say standardizing a supplement to toddlers’ diets is impossible because no two children are alike.

In focus groups, Dr. Harris said, parents report feeding their children toddler formula to fill nutritional gaps when a child isn’t eating enough, a common concern among parents.

“Infants are often voracious eaters,” said Stephen Daniels, MD, chair of pediatrics at Children’s Hospital Colorado, Aurora. But at around a year of age, children’s growth plateaus, he said, and “they’re suddenly not hungry in the way they used to be anymore.” That can worry parents, he added, but “it’s a completely normal phenomenon.”

If parents have concerns about their children’s diet, Dr. Daniels said, they should consult a pediatrician or family doctor.

Blanche Lincoln, president of the Infant Nutrition Council of America, which represents the makers of Enfamil, Gerber, Similac, and store brands, said in an email that the toddler formulas can be helpful because they can fill “nutritional gaps during this period of transition to table foods.” Ms. Lincoln, a former U.S. senator from Arkansas, said the drinks “help contribute to the specific nutritional needs of toddlers by providing energy and important nutrients, as well as essential vitamins and minerals during this important period of growth and development.”

But toddler formula isn’t being ingested by toddlers alone – it’s also being fed to infants. In a recent study, Dr. Porto and colleagues found that 5% of infants’ parents reported giving their babies drinks marketed for the older age group. And Dr. Harris’ research indicated that 22% of parents of infants older than 6 months had fed their babies toddler formula in the previous month. Both studies were conducted before the recent infant formula shortage, which may have exacerbated the problem.

“Infant formulas and toddler formulas tend to be next to each other in the supermarket,” Dr. Harris said. “They look similar, but the toddler formulas are cheaper than the infant formulas. So people confuse them, and they grab the wrong one. Or they think: ‘Oh, this one is less expensive. I’ll get this one instead.’ ”

According to an email from Food and Drug Administration spokesperson Lindsay Haake, toddler drinks do not meet the definition of infant formula, so they are not subject to the same requirements. That means they do not have to undergo the clinical trials and pathogen safety testing that the infant versions do. “Unlike infant formulas, toddler formulas are not necessary to meet the nutritional needs of their intended consumers,” Ms. Haake said.

In a statement to KHN, the Infant Nutrition Council of America said: “Toddler drinks have a distinctive use and nutritional makeup from infant formula; the two are not interchangeable. The labeling of toddler nutritional drinks explicitly identifies the product as a toddler drink intended for children 12 months and older on the front of the package label.”

However, several expensive toddler formula brands made by smaller companies – often advertised as being made from goat milk, A2 whole milk (which lacks one common milk protein), or vegan ingredients that aren’t soy – do meet nutritional requirements for infants, and some advertise that.

Dr. Harris argued that this confuses parents, too, and shouldn’t be allowed. Just because a toddler formula has the nutritional ingredients required by the FDA for infant formula doesn’t mean it has met the other tests required of infant formula.

Federal regulators have not forced any of the companies to withdraw those products. In an email, FDA spokesperson Marianna Naum said: “The FDA does not comment on potential compliance actions.”

One company, Nature’s One, whose toddler formulas are named “Baby’s Only,” received warning letters a decade ago from the FDA about marketing them for infants. That case was closed in 2016. The company’s website says that Baby’s Only formula “meets nutrient requirements for infant” and that “Baby’s Only Organic® can be served up to 3 years of age.” Critics say that language implies the formula is fine for babies younger than 1. The company’s website and its Instagram account feature customer testimonials from parents who report feeding the formula to their infants, as well as pictures of infants drinking it.

Jay Highman, CEO and president of Nature’s One, said that Baby’s Only is clearly labeled as a toddler formula and that the back of the can states that “Baby’s Only is intended for a toddler 1 year of age or older OR when directed by a health care professional.” He also said that since the company launched in 1999, its formulas have met all the nutritional, manufacturing, and safety standards required of infant formula even though they don’t have to. “We behaved like we are an infant formula, but we were selling it as a toddler formula.”

He said that the clinical trials required by the FDA are a huge barrier to bringing a new infant formula to market and that many other countries don’t require a clinical trial. Baby’s Only recently completed a clinical trial, and the company expects to be able to sell it as an infant formula soon.

Yet pediatricians and nutritional experts continue to caution parents about using the toddler drinks. “There’s no question that infant formula is very important in the first year of life,” Dr. Daniels said. But he doesn’t recommend the toddler version “because it’s not that useful, because it’s confusing, because it’s expensive.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Formulas for toddlers are a burgeoning business in the United States: Sales of the drinks more than doubled in recent years as companies convinced parents that their little ones needed the liquid boost. But many experts warn that these products, designed for children ages 1-3, fill no nutritional needs beyond what is available in a typical toddler diet, are subject to less regulation than infant formula, and are expensive.

In addition, some parents feed the toddler versions to infants even though they do not meet federal standards for infant formula and may not provide babies with adequate nutrients to sustain their growth.

Pediatricians and federal health officials say that when most children turn 1, they can begin drinking cow milk or an unsweetened plant-based milk substitute. In a 2019 “consensus” statement, the American Academy of Pediatrics and other health and nutrition organizations recommended against using toddler formulas, saying “they offer no unique nutritional value beyond what could be obtained with healthy foods; furthermore, they may contribute added sugars to the diet.” The toddler formulas often contain sweeteners and fats that add calories.

Some of the same companies that produce infant formula – including Enfamil, Gerber, and Similac – also make toddler formulas, as do some smaller, boutique brands that advertise that they have organic or other special qualities. Toddler formulas are available nearly everywhere infant formulas are sold and are marketed as providing extra nutrients to help children’s brain, immune system, and eye development, among other benefits. They are different from medical formulas prescribed for children with specific needs.

A 2020 study found that sales of toddler formula in the United States rose to $92 million in 2015 from $39 million in 2006.

Parents are often confused by the marketing for the formulas, according to a study led by Jennifer Harris, PhD, a marketing and public health researcher at the University of Connecticut, Hartford. She found that 60% of caregivers falsely believed toddler formulas have nutrients that toddlers can’t get from other foods.

Anthony Porto, MD, MPH, a pediatric gastroenterologist and pediatrics professor at Yale University, New Haven, Conn., said he is concerned these products could be giving toddlers more nutrients and calories than they need. Unlike what’s designed for infants, toddler formula has no nutritional regulations: Experts say standardizing a supplement to toddlers’ diets is impossible because no two children are alike.

In focus groups, Dr. Harris said, parents report feeding their children toddler formula to fill nutritional gaps when a child isn’t eating enough, a common concern among parents.

“Infants are often voracious eaters,” said Stephen Daniels, MD, chair of pediatrics at Children’s Hospital Colorado, Aurora. But at around a year of age, children’s growth plateaus, he said, and “they’re suddenly not hungry in the way they used to be anymore.” That can worry parents, he added, but “it’s a completely normal phenomenon.”

If parents have concerns about their children’s diet, Dr. Daniels said, they should consult a pediatrician or family doctor.

Blanche Lincoln, president of the Infant Nutrition Council of America, which represents the makers of Enfamil, Gerber, Similac, and store brands, said in an email that the toddler formulas can be helpful because they can fill “nutritional gaps during this period of transition to table foods.” Ms. Lincoln, a former U.S. senator from Arkansas, said the drinks “help contribute to the specific nutritional needs of toddlers by providing energy and important nutrients, as well as essential vitamins and minerals during this important period of growth and development.”

But toddler formula isn’t being ingested by toddlers alone – it’s also being fed to infants. In a recent study, Dr. Porto and colleagues found that 5% of infants’ parents reported giving their babies drinks marketed for the older age group. And Dr. Harris’ research indicated that 22% of parents of infants older than 6 months had fed their babies toddler formula in the previous month. Both studies were conducted before the recent infant formula shortage, which may have exacerbated the problem.

“Infant formulas and toddler formulas tend to be next to each other in the supermarket,” Dr. Harris said. “They look similar, but the toddler formulas are cheaper than the infant formulas. So people confuse them, and they grab the wrong one. Or they think: ‘Oh, this one is less expensive. I’ll get this one instead.’ ”

According to an email from Food and Drug Administration spokesperson Lindsay Haake, toddler drinks do not meet the definition of infant formula, so they are not subject to the same requirements. That means they do not have to undergo the clinical trials and pathogen safety testing that the infant versions do. “Unlike infant formulas, toddler formulas are not necessary to meet the nutritional needs of their intended consumers,” Ms. Haake said.

In a statement to KHN, the Infant Nutrition Council of America said: “Toddler drinks have a distinctive use and nutritional makeup from infant formula; the two are not interchangeable. The labeling of toddler nutritional drinks explicitly identifies the product as a toddler drink intended for children 12 months and older on the front of the package label.”

However, several expensive toddler formula brands made by smaller companies – often advertised as being made from goat milk, A2 whole milk (which lacks one common milk protein), or vegan ingredients that aren’t soy – do meet nutritional requirements for infants, and some advertise that.

Dr. Harris argued that this confuses parents, too, and shouldn’t be allowed. Just because a toddler formula has the nutritional ingredients required by the FDA for infant formula doesn’t mean it has met the other tests required of infant formula.

Federal regulators have not forced any of the companies to withdraw those products. In an email, FDA spokesperson Marianna Naum said: “The FDA does not comment on potential compliance actions.”

One company, Nature’s One, whose toddler formulas are named “Baby’s Only,” received warning letters a decade ago from the FDA about marketing them for infants. That case was closed in 2016. The company’s website says that Baby’s Only formula “meets nutrient requirements for infant” and that “Baby’s Only Organic® can be served up to 3 years of age.” Critics say that language implies the formula is fine for babies younger than 1. The company’s website and its Instagram account feature customer testimonials from parents who report feeding the formula to their infants, as well as pictures of infants drinking it.

Jay Highman, CEO and president of Nature’s One, said that Baby’s Only is clearly labeled as a toddler formula and that the back of the can states that “Baby’s Only is intended for a toddler 1 year of age or older OR when directed by a health care professional.” He also said that since the company launched in 1999, its formulas have met all the nutritional, manufacturing, and safety standards required of infant formula even though they don’t have to. “We behaved like we are an infant formula, but we were selling it as a toddler formula.”

He said that the clinical trials required by the FDA are a huge barrier to bringing a new infant formula to market and that many other countries don’t require a clinical trial. Baby’s Only recently completed a clinical trial, and the company expects to be able to sell it as an infant formula soon.

Yet pediatricians and nutritional experts continue to caution parents about using the toddler drinks. “There’s no question that infant formula is very important in the first year of life,” Dr. Daniels said. But he doesn’t recommend the toddler version “because it’s not that useful, because it’s confusing, because it’s expensive.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Formulas for toddlers are a burgeoning business in the United States: Sales of the drinks more than doubled in recent years as companies convinced parents that their little ones needed the liquid boost. But many experts warn that these products, designed for children ages 1-3, fill no nutritional needs beyond what is available in a typical toddler diet, are subject to less regulation than infant formula, and are expensive.

In addition, some parents feed the toddler versions to infants even though they do not meet federal standards for infant formula and may not provide babies with adequate nutrients to sustain their growth.

Pediatricians and federal health officials say that when most children turn 1, they can begin drinking cow milk or an unsweetened plant-based milk substitute. In a 2019 “consensus” statement, the American Academy of Pediatrics and other health and nutrition organizations recommended against using toddler formulas, saying “they offer no unique nutritional value beyond what could be obtained with healthy foods; furthermore, they may contribute added sugars to the diet.” The toddler formulas often contain sweeteners and fats that add calories.

Some of the same companies that produce infant formula – including Enfamil, Gerber, and Similac – also make toddler formulas, as do some smaller, boutique brands that advertise that they have organic or other special qualities. Toddler formulas are available nearly everywhere infant formulas are sold and are marketed as providing extra nutrients to help children’s brain, immune system, and eye development, among other benefits. They are different from medical formulas prescribed for children with specific needs.

A 2020 study found that sales of toddler formula in the United States rose to $92 million in 2015 from $39 million in 2006.

Parents are often confused by the marketing for the formulas, according to a study led by Jennifer Harris, PhD, a marketing and public health researcher at the University of Connecticut, Hartford. She found that 60% of caregivers falsely believed toddler formulas have nutrients that toddlers can’t get from other foods.

Anthony Porto, MD, MPH, a pediatric gastroenterologist and pediatrics professor at Yale University, New Haven, Conn., said he is concerned these products could be giving toddlers more nutrients and calories than they need. Unlike what’s designed for infants, toddler formula has no nutritional regulations: Experts say standardizing a supplement to toddlers’ diets is impossible because no two children are alike.

In focus groups, Dr. Harris said, parents report feeding their children toddler formula to fill nutritional gaps when a child isn’t eating enough, a common concern among parents.

“Infants are often voracious eaters,” said Stephen Daniels, MD, chair of pediatrics at Children’s Hospital Colorado, Aurora. But at around a year of age, children’s growth plateaus, he said, and “they’re suddenly not hungry in the way they used to be anymore.” That can worry parents, he added, but “it’s a completely normal phenomenon.”

If parents have concerns about their children’s diet, Dr. Daniels said, they should consult a pediatrician or family doctor.

Blanche Lincoln, president of the Infant Nutrition Council of America, which represents the makers of Enfamil, Gerber, Similac, and store brands, said in an email that the toddler formulas can be helpful because they can fill “nutritional gaps during this period of transition to table foods.” Ms. Lincoln, a former U.S. senator from Arkansas, said the drinks “help contribute to the specific nutritional needs of toddlers by providing energy and important nutrients, as well as essential vitamins and minerals during this important period of growth and development.”

But toddler formula isn’t being ingested by toddlers alone – it’s also being fed to infants. In a recent study, Dr. Porto and colleagues found that 5% of infants’ parents reported giving their babies drinks marketed for the older age group. And Dr. Harris’ research indicated that 22% of parents of infants older than 6 months had fed their babies toddler formula in the previous month. Both studies were conducted before the recent infant formula shortage, which may have exacerbated the problem.

“Infant formulas and toddler formulas tend to be next to each other in the supermarket,” Dr. Harris said. “They look similar, but the toddler formulas are cheaper than the infant formulas. So people confuse them, and they grab the wrong one. Or they think: ‘Oh, this one is less expensive. I’ll get this one instead.’ ”

According to an email from Food and Drug Administration spokesperson Lindsay Haake, toddler drinks do not meet the definition of infant formula, so they are not subject to the same requirements. That means they do not have to undergo the clinical trials and pathogen safety testing that the infant versions do. “Unlike infant formulas, toddler formulas are not necessary to meet the nutritional needs of their intended consumers,” Ms. Haake said.

In a statement to KHN, the Infant Nutrition Council of America said: “Toddler drinks have a distinctive use and nutritional makeup from infant formula; the two are not interchangeable. The labeling of toddler nutritional drinks explicitly identifies the product as a toddler drink intended for children 12 months and older on the front of the package label.”

However, several expensive toddler formula brands made by smaller companies – often advertised as being made from goat milk, A2 whole milk (which lacks one common milk protein), or vegan ingredients that aren’t soy – do meet nutritional requirements for infants, and some advertise that.

Dr. Harris argued that this confuses parents, too, and shouldn’t be allowed. Just because a toddler formula has the nutritional ingredients required by the FDA for infant formula doesn’t mean it has met the other tests required of infant formula.

Federal regulators have not forced any of the companies to withdraw those products. In an email, FDA spokesperson Marianna Naum said: “The FDA does not comment on potential compliance actions.”

One company, Nature’s One, whose toddler formulas are named “Baby’s Only,” received warning letters a decade ago from the FDA about marketing them for infants. That case was closed in 2016. The company’s website says that Baby’s Only formula “meets nutrient requirements for infant” and that “Baby’s Only Organic® can be served up to 3 years of age.” Critics say that language implies the formula is fine for babies younger than 1. The company’s website and its Instagram account feature customer testimonials from parents who report feeding the formula to their infants, as well as pictures of infants drinking it.

Jay Highman, CEO and president of Nature’s One, said that Baby’s Only is clearly labeled as a toddler formula and that the back of the can states that “Baby’s Only is intended for a toddler 1 year of age or older OR when directed by a health care professional.” He also said that since the company launched in 1999, its formulas have met all the nutritional, manufacturing, and safety standards required of infant formula even though they don’t have to. “We behaved like we are an infant formula, but we were selling it as a toddler formula.”

He said that the clinical trials required by the FDA are a huge barrier to bringing a new infant formula to market and that many other countries don’t require a clinical trial. Baby’s Only recently completed a clinical trial, and the company expects to be able to sell it as an infant formula soon.

Yet pediatricians and nutritional experts continue to caution parents about using the toddler drinks. “There’s no question that infant formula is very important in the first year of life,” Dr. Daniels said. But he doesn’t recommend the toddler version “because it’s not that useful, because it’s confusing, because it’s expensive.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.