IBD & Intestinal Disorders

Even without GI symptoms, many patients with COVID-19 shed viral RNA in feces, suggesting that stool testing and prevention of fecal-oral transmission may be needed to combat the ongoing pandemic, according to investigators.

A meta-analysis of 29 studies showed that 12% of patients with COVID-19 developed nausea, diarrhea, or vomiting, while 41% shed viral RNA in feces, reported lead author Sravanthi Parasa, MD, of Swedish Medical Center, Seattle.Writing in JAMA Network Open, Dr. Parasa and colleagues emphasized that respiratory symptoms remain the predominant form of disease; however, GI symptoms can occur.

“In fact, the first reported patient with COVID-19 in the U.S. reported GI symptoms of loose bowel movements and abdominal discomfort,” the investigators wrote, noting that the patient went on to test positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in both respiratory and stool specimens.

“This raises the question of inadvertent human-to-human transmission via the fecal route despite public health emphasis on droplet transmission and precautions for contact with respiratory secretions,” the investigators wrote.

To address this question, the investigators conducted a systematic review and meta-analysis involving 23 published and 6 preprint studies involving a total of 4,805 patients, all of whom tested positive for SARS-CoV-2 based on PCR results from nasopharyngeal swabs. Dr. Parasa and colleagues noted that most of the studies “scored between 8 and 10 on the MINORS quality assessment,” suggesting moderate quality.

Pooled data from these studies showed that 4.6% of patients reported nausea or vomiting, while 7.4% reported diarrhea. Such symptoms may serve as an early warning flag for clinicians, the investigators noted.

“[T]he presence of GI symptoms may portend a worse outcome for patients infected with SARS-CoV-2,” they wrote, citing a study by Pan and colleagues, which found that GI symptoms were associated with lower rates of recovery and hospital discharge.

Regardless of GI symptoms, 40.5% of patients in the meta-analysis tested positive for viral RNA in feces (95% confidence interval, 27.4%-55.1%). Duration of viral shedding in feces lasted up to 11 days after symptom onset, or in a single-patient case study, 18 days after hospitalization.

The investigators called these duration figures “particularly concerning,” especially in light of a study published by Xiao and colleagues, which showed that 23.3% of patients with negative respiratory tests were still shedding live virus in feces.

“[T]he fecal-oral route of transmission could be an additional potential source of infection spread,” wrote Dr. Parasa and colleagues. “Our results also suggest that testing of the virus in feces ... could be helpful in disease monitoring and surveillance.”

David A. Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School in Norfolk, said that the findings confirm what has been suspected for some time: GI disease is relatively common with COVID-19.

“The evidence is clear now that a sizable percentage of patients have GI symptoms,” Dr. Johnson said in an interview.

GI issues may precede respiratory signs, he added, so clinicians should be aware that nausea, vomiting, or diarrhea could be early indicators of COVID-19, and possibly, a worse outcome.

“The other highlight of this study is that stool shedding may be extended beyond respiratory shedding,” Dr. Johnson said.

He suggested that this finding could influence current CDC criteria, which define absence of infectious risk by two consecutive, negative nasopharyngeal swabs. Instead, fecal testing may be needed, he said, along with measures to prevent fecal-oral transmission.

Dr. Johnson expressed particular concern for risk of infection via toilet plume, in which toilet flushing aerosolizes viral particles.

“As much as people try to social distance by 6 feet – you can do that when you walk into a store, or a building, but you can’t necessarily do that when you walk into a public toilet, where the plume may have been expansive for a period of time,” he said. “That toilet may never really get cleaned to a high level of disinfection, and those droplets set up potential for fecal-oral spread.”

Dr. Sharma disclosed relationships with Medtronic, Fujifilm, Boston Scientific, and others. Dr. Johnson disclosed no relevant conflicts of interest.

SOURCE: Parasa S et al. JAMA Network Open. 2020 Jun 11. doi: 10.1001/jamanetworkopen.2020.11335.

Even without GI symptoms, many patients with COVID-19 shed viral RNA in feces, suggesting that stool testing and prevention of fecal-oral transmission may be needed to combat the ongoing pandemic, according to investigators.

A meta-analysis of 29 studies showed that 12% of patients with COVID-19 developed nausea, diarrhea, or vomiting, while 41% shed viral RNA in feces, reported lead author Sravanthi Parasa, MD, of Swedish Medical Center, Seattle.Writing in JAMA Network Open, Dr. Parasa and colleagues emphasized that respiratory symptoms remain the predominant form of disease; however, GI symptoms can occur.

“In fact, the first reported patient with COVID-19 in the U.S. reported GI symptoms of loose bowel movements and abdominal discomfort,” the investigators wrote, noting that the patient went on to test positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in both respiratory and stool specimens.

“This raises the question of inadvertent human-to-human transmission via the fecal route despite public health emphasis on droplet transmission and precautions for contact with respiratory secretions,” the investigators wrote.

To address this question, the investigators conducted a systematic review and meta-analysis involving 23 published and 6 preprint studies involving a total of 4,805 patients, all of whom tested positive for SARS-CoV-2 based on PCR results from nasopharyngeal swabs. Dr. Parasa and colleagues noted that most of the studies “scored between 8 and 10 on the MINORS quality assessment,” suggesting moderate quality.

Pooled data from these studies showed that 4.6% of patients reported nausea or vomiting, while 7.4% reported diarrhea. Such symptoms may serve as an early warning flag for clinicians, the investigators noted.

“[T]he presence of GI symptoms may portend a worse outcome for patients infected with SARS-CoV-2,” they wrote, citing a study by Pan and colleagues, which found that GI symptoms were associated with lower rates of recovery and hospital discharge.

Regardless of GI symptoms, 40.5% of patients in the meta-analysis tested positive for viral RNA in feces (95% confidence interval, 27.4%-55.1%). Duration of viral shedding in feces lasted up to 11 days after symptom onset, or in a single-patient case study, 18 days after hospitalization.

The investigators called these duration figures “particularly concerning,” especially in light of a study published by Xiao and colleagues, which showed that 23.3% of patients with negative respiratory tests were still shedding live virus in feces.

“[T]he fecal-oral route of transmission could be an additional potential source of infection spread,” wrote Dr. Parasa and colleagues. “Our results also suggest that testing of the virus in feces ... could be helpful in disease monitoring and surveillance.”

David A. Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School in Norfolk, said that the findings confirm what has been suspected for some time: GI disease is relatively common with COVID-19.

“The evidence is clear now that a sizable percentage of patients have GI symptoms,” Dr. Johnson said in an interview.

GI issues may precede respiratory signs, he added, so clinicians should be aware that nausea, vomiting, or diarrhea could be early indicators of COVID-19, and possibly, a worse outcome.

“The other highlight of this study is that stool shedding may be extended beyond respiratory shedding,” Dr. Johnson said.

He suggested that this finding could influence current CDC criteria, which define absence of infectious risk by two consecutive, negative nasopharyngeal swabs. Instead, fecal testing may be needed, he said, along with measures to prevent fecal-oral transmission.

Dr. Johnson expressed particular concern for risk of infection via toilet plume, in which toilet flushing aerosolizes viral particles.

“As much as people try to social distance by 6 feet – you can do that when you walk into a store, or a building, but you can’t necessarily do that when you walk into a public toilet, where the plume may have been expansive for a period of time,” he said. “That toilet may never really get cleaned to a high level of disinfection, and those droplets set up potential for fecal-oral spread.”

Dr. Sharma disclosed relationships with Medtronic, Fujifilm, Boston Scientific, and others. Dr. Johnson disclosed no relevant conflicts of interest.

SOURCE: Parasa S et al. JAMA Network Open. 2020 Jun 11. doi: 10.1001/jamanetworkopen.2020.11335.

Even without GI symptoms, many patients with COVID-19 shed viral RNA in feces, suggesting that stool testing and prevention of fecal-oral transmission may be needed to combat the ongoing pandemic, according to investigators.

A meta-analysis of 29 studies showed that 12% of patients with COVID-19 developed nausea, diarrhea, or vomiting, while 41% shed viral RNA in feces, reported lead author Sravanthi Parasa, MD, of Swedish Medical Center, Seattle.Writing in JAMA Network Open, Dr. Parasa and colleagues emphasized that respiratory symptoms remain the predominant form of disease; however, GI symptoms can occur.

“In fact, the first reported patient with COVID-19 in the U.S. reported GI symptoms of loose bowel movements and abdominal discomfort,” the investigators wrote, noting that the patient went on to test positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in both respiratory and stool specimens.

“This raises the question of inadvertent human-to-human transmission via the fecal route despite public health emphasis on droplet transmission and precautions for contact with respiratory secretions,” the investigators wrote.

To address this question, the investigators conducted a systematic review and meta-analysis involving 23 published and 6 preprint studies involving a total of 4,805 patients, all of whom tested positive for SARS-CoV-2 based on PCR results from nasopharyngeal swabs. Dr. Parasa and colleagues noted that most of the studies “scored between 8 and 10 on the MINORS quality assessment,” suggesting moderate quality.

Pooled data from these studies showed that 4.6% of patients reported nausea or vomiting, while 7.4% reported diarrhea. Such symptoms may serve as an early warning flag for clinicians, the investigators noted.

“[T]he presence of GI symptoms may portend a worse outcome for patients infected with SARS-CoV-2,” they wrote, citing a study by Pan and colleagues, which found that GI symptoms were associated with lower rates of recovery and hospital discharge.

Regardless of GI symptoms, 40.5% of patients in the meta-analysis tested positive for viral RNA in feces (95% confidence interval, 27.4%-55.1%). Duration of viral shedding in feces lasted up to 11 days after symptom onset, or in a single-patient case study, 18 days after hospitalization.

The investigators called these duration figures “particularly concerning,” especially in light of a study published by Xiao and colleagues, which showed that 23.3% of patients with negative respiratory tests were still shedding live virus in feces.

“[T]he fecal-oral route of transmission could be an additional potential source of infection spread,” wrote Dr. Parasa and colleagues. “Our results also suggest that testing of the virus in feces ... could be helpful in disease monitoring and surveillance.”

David A. Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School in Norfolk, said that the findings confirm what has been suspected for some time: GI disease is relatively common with COVID-19.

“The evidence is clear now that a sizable percentage of patients have GI symptoms,” Dr. Johnson said in an interview.

GI issues may precede respiratory signs, he added, so clinicians should be aware that nausea, vomiting, or diarrhea could be early indicators of COVID-19, and possibly, a worse outcome.

“The other highlight of this study is that stool shedding may be extended beyond respiratory shedding,” Dr. Johnson said.

He suggested that this finding could influence current CDC criteria, which define absence of infectious risk by two consecutive, negative nasopharyngeal swabs. Instead, fecal testing may be needed, he said, along with measures to prevent fecal-oral transmission.

Dr. Johnson expressed particular concern for risk of infection via toilet plume, in which toilet flushing aerosolizes viral particles.

“As much as people try to social distance by 6 feet – you can do that when you walk into a store, or a building, but you can’t necessarily do that when you walk into a public toilet, where the plume may have been expansive for a period of time,” he said. “That toilet may never really get cleaned to a high level of disinfection, and those droplets set up potential for fecal-oral spread.”

Dr. Sharma disclosed relationships with Medtronic, Fujifilm, Boston Scientific, and others. Dr. Johnson disclosed no relevant conflicts of interest.

SOURCE: Parasa S et al. JAMA Network Open. 2020 Jun 11. doi: 10.1001/jamanetworkopen.2020.11335.

Inflammatory bowel disease (IBD) does not seem to make patients any more likely to contract SARS-COV-2 or develop COVID-19, but a rapid review commissioned by the American Gastroenterological Association acknowledges that determination is based on limited evidence and IBD patients should nonetheless maintain remission to reduce their risk of relapse or hospitalization during the COVID-19 pandemic.

The AGA has published a clinical practice update based on that rapid review online in Gastroenterology (2020. doi: 10.1053/j.gastro.2020.04.012).

Because of the widespread use of immunosuppressive or immune-modifying drugs, “It is understandable why patients with Crohn’s disease and ulcerative colitis have specific concerns and potential for increased risk of infection with SARS-CoV-2,” wrote David T. Rubin, MD, AGAF, of the University of Chicago and colleagues in the expert commentary.

They noted that, while association between GI symptoms and COVID-19 RNA in stool samples isn’t clear, given the reports of GI symptoms in COVID-19 patients – ranging from 10% (JAMA. 2020:323:1061-9) to half of patients (Am J Gastroenterol. 2020;115:766-73) – “the clinical implications of this are quite important.” In IBD patients, changes in digestive symptoms without accompanying fever or respiratory symptoms can be monitored for symptoms that could merit testing for the virus as well as “trigger additional treatment adjustments.”

In accordance with the IOIBD (International Organization for the Study of Inflammatory Bowel Disease) consensus, the update noted that IBD patients should continue going to infusion centers for therapies, provided that the centers use a COVID-19 screening protocol.

Patients with IBD who contract COVID-19 seem more likely to be hospitalized for one or the other disease, but that’s based on data from the international SECURE-IBD registry that had 164 patients as of the writing of the update. The update provides guidance for three scenarios for IBD patients during the pandemic:

• Patients not infected with SARS-CoV-2 should maintain their IBD therapies to sustain remission and avoid relapses. “Aside from the obvious negative consequences of a relapse, relapsing IBD will strain available medical resources, may require steroid therapy or necessitate hospitalization, outcomes that are all much worse than the known risks of existing IBD therapies,” Dr. Rubin and colleagues noted.
• Patients who are infected but have no symptoms of COVID-19 should have their dosing of prednisone adjusted to less than 20 mg/day or switched to budesonide; suspend thiopurines, methotrexate, and tofacitinib; and delay dosing of monoclonal antibodies (anti–tumor necrosis factor [anti-TNF] drugs, ustekinumab, or vedolizumab) for 2 weeks while their symptoms for COVID-19 are monitored. “Restarting therapy after 2 weeks if the patient has not developed manifestations of COVID-19 is reasonable,” wrote Dr. Rubin and colleagues. Emerging serial testing should indicate antibody status, but the effectiveness of stool testing for SARS-CoV-2 in these cases “remains to be seen.”
• In the patient with confirmed COVID-19, adjustment of IBD therapy “is appropriate, based on the understanding of the immune activity of the therapy and whether that therapy may worsen outcomes with COVID-19,” the update stated. Therapy adjustment should focus on reducing immune suppression during the active viral infection. Some studies are evaluating anticytokine-based therapies as COVID-19 treatments, so continued anti-TNF therapies might prevent acute respiratory distress syndrome and multiorgan failure, Dr. Rubin and colleagues wrote. “However, in the absence of those data, guidance is currently based on deciding whether to hold or to continue specific IBD therapies.”

The update considers most IBD therapies, specifically aminosalicylates, topical rectal therapy, dietary management, and antibiotics “safe and may be continued,” and oral budesonide can be continued if it’s needed for ongoing IBD control. However, corticosteroids “should be avoided and discontinued quickly.”

Likewise, during the acute stage of COVID-19, thiopurines, methotrexate, and tofacitinib should be discontinued, and anti-TNF drugs and ustekinumab should be stopped during viral illness. Holding vedolizumab during viral illness is also appropriate, according to the update, although the IOIBD group was uncertain if doing so was necessary.

If the IBD patient has digestive symptoms with COVID-19, ongoing supportive care of the COVID-19 is “reasonable,” but investigating the causes of the digestive symptoms “is critically important.” That should include ruling out enteric infections and confirming active inflammation with nonendoscopic testing. Endoscopy should be relegated to only urgent and emergent cases.

Management of IBD in COVID-19 patients also depends on disease severity. Safer therapies are indicated for mild disease, but withholding IBD therapy in moderate to severe cases may not be practical. “In this setting, the risks and benefits of escalating IBD therapy must be carefully weighed against the severity of the COVID-19,” Dr. Rubin and colleagues noted.

In hospitalized patients with severe COVID-19 and poor prognoses, “IBD therapy will likely take a back seat,” the update stated, although COVID-19 therapies should take the concomitant IBD into account. In patients with milder cases of COVID-19, IBD management should focus on acute manifestations, but intravenous steroid therapy shouldn’t exceed 3 days. The update urged providers to submit cases of IBD and confirmed COVID-19 to the SECURE-IBD registry at COVIDIBD.org.

Dr. Rubin disclosed financial relationships with AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene/Syneos, Gilead Sciences, Takeda, and many other pharmaceutical companies. Coauthors disclosed relationships with those companies and Medimmune, Novus Therapeutics, Osiris Therapeutics, RedHill Biopharma, Sanofi-Aventis, UCB Pharma, and multiple other pharmaceutical companies.

SOURCE: Rubin DT, et al. Gastroenterology. 2020:  doi: 10.1053/j.gastro.2020.04.012

Inflammatory bowel disease (IBD) does not seem to make patients any more likely to contract SARS-COV-2 or develop COVID-19, but a rapid review commissioned by the American Gastroenterological Association acknowledges that determination is based on limited evidence and IBD patients should nonetheless maintain remission to reduce their risk of relapse or hospitalization during the COVID-19 pandemic.

The AGA has published a clinical practice update based on that rapid review online in Gastroenterology (2020. doi: 10.1053/j.gastro.2020.04.012).

Because of the widespread use of immunosuppressive or immune-modifying drugs, “It is understandable why patients with Crohn’s disease and ulcerative colitis have specific concerns and potential for increased risk of infection with SARS-CoV-2,” wrote David T. Rubin, MD, AGAF, of the University of Chicago and colleagues in the expert commentary.

They noted that, while association between GI symptoms and COVID-19 RNA in stool samples isn’t clear, given the reports of GI symptoms in COVID-19 patients – ranging from 10% (JAMA. 2020:323:1061-9) to half of patients (Am J Gastroenterol. 2020;115:766-73) – “the clinical implications of this are quite important.” In IBD patients, changes in digestive symptoms without accompanying fever or respiratory symptoms can be monitored for symptoms that could merit testing for the virus as well as “trigger additional treatment adjustments.”

In accordance with the IOIBD (International Organization for the Study of Inflammatory Bowel Disease) consensus, the update noted that IBD patients should continue going to infusion centers for therapies, provided that the centers use a COVID-19 screening protocol.

Patients with IBD who contract COVID-19 seem more likely to be hospitalized for one or the other disease, but that’s based on data from the international SECURE-IBD registry that had 164 patients as of the writing of the update. The update provides guidance for three scenarios for IBD patients during the pandemic:

• Patients not infected with SARS-CoV-2 should maintain their IBD therapies to sustain remission and avoid relapses. “Aside from the obvious negative consequences of a relapse, relapsing IBD will strain available medical resources, may require steroid therapy or necessitate hospitalization, outcomes that are all much worse than the known risks of existing IBD therapies,” Dr. Rubin and colleagues noted.
• Patients who are infected but have no symptoms of COVID-19 should have their dosing of prednisone adjusted to less than 20 mg/day or switched to budesonide; suspend thiopurines, methotrexate, and tofacitinib; and delay dosing of monoclonal antibodies (anti–tumor necrosis factor [anti-TNF] drugs, ustekinumab, or vedolizumab) for 2 weeks while their symptoms for COVID-19 are monitored. “Restarting therapy after 2 weeks if the patient has not developed manifestations of COVID-19 is reasonable,” wrote Dr. Rubin and colleagues. Emerging serial testing should indicate antibody status, but the effectiveness of stool testing for SARS-CoV-2 in these cases “remains to be seen.”
• In the patient with confirmed COVID-19, adjustment of IBD therapy “is appropriate, based on the understanding of the immune activity of the therapy and whether that therapy may worsen outcomes with COVID-19,” the update stated. Therapy adjustment should focus on reducing immune suppression during the active viral infection. Some studies are evaluating anticytokine-based therapies as COVID-19 treatments, so continued anti-TNF therapies might prevent acute respiratory distress syndrome and multiorgan failure, Dr. Rubin and colleagues wrote. “However, in the absence of those data, guidance is currently based on deciding whether to hold or to continue specific IBD therapies.”

The update considers most IBD therapies, specifically aminosalicylates, topical rectal therapy, dietary management, and antibiotics “safe and may be continued,” and oral budesonide can be continued if it’s needed for ongoing IBD control. However, corticosteroids “should be avoided and discontinued quickly.”

Likewise, during the acute stage of COVID-19, thiopurines, methotrexate, and tofacitinib should be discontinued, and anti-TNF drugs and ustekinumab should be stopped during viral illness. Holding vedolizumab during viral illness is also appropriate, according to the update, although the IOIBD group was uncertain if doing so was necessary.

If the IBD patient has digestive symptoms with COVID-19, ongoing supportive care of the COVID-19 is “reasonable,” but investigating the causes of the digestive symptoms “is critically important.” That should include ruling out enteric infections and confirming active inflammation with nonendoscopic testing. Endoscopy should be relegated to only urgent and emergent cases.

Management of IBD in COVID-19 patients also depends on disease severity. Safer therapies are indicated for mild disease, but withholding IBD therapy in moderate to severe cases may not be practical. “In this setting, the risks and benefits of escalating IBD therapy must be carefully weighed against the severity of the COVID-19,” Dr. Rubin and colleagues noted.

In hospitalized patients with severe COVID-19 and poor prognoses, “IBD therapy will likely take a back seat,” the update stated, although COVID-19 therapies should take the concomitant IBD into account. In patients with milder cases of COVID-19, IBD management should focus on acute manifestations, but intravenous steroid therapy shouldn’t exceed 3 days. The update urged providers to submit cases of IBD and confirmed COVID-19 to the SECURE-IBD registry at COVIDIBD.org.

Dr. Rubin disclosed financial relationships with AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene/Syneos, Gilead Sciences, Takeda, and many other pharmaceutical companies. Coauthors disclosed relationships with those companies and Medimmune, Novus Therapeutics, Osiris Therapeutics, RedHill Biopharma, Sanofi-Aventis, UCB Pharma, and multiple other pharmaceutical companies.

SOURCE: Rubin DT, et al. Gastroenterology. 2020:  doi: 10.1053/j.gastro.2020.04.012

Inflammatory bowel disease (IBD) does not seem to make patients any more likely to contract SARS-COV-2 or develop COVID-19, but a rapid review commissioned by the American Gastroenterological Association acknowledges that determination is based on limited evidence and IBD patients should nonetheless maintain remission to reduce their risk of relapse or hospitalization during the COVID-19 pandemic.

The AGA has published a clinical practice update based on that rapid review online in Gastroenterology (2020. doi: 10.1053/j.gastro.2020.04.012).

Because of the widespread use of immunosuppressive or immune-modifying drugs, “It is understandable why patients with Crohn’s disease and ulcerative colitis have specific concerns and potential for increased risk of infection with SARS-CoV-2,” wrote David T. Rubin, MD, AGAF, of the University of Chicago and colleagues in the expert commentary.

They noted that, while association between GI symptoms and COVID-19 RNA in stool samples isn’t clear, given the reports of GI symptoms in COVID-19 patients – ranging from 10% (JAMA. 2020:323:1061-9) to half of patients (Am J Gastroenterol. 2020;115:766-73) – “the clinical implications of this are quite important.” In IBD patients, changes in digestive symptoms without accompanying fever or respiratory symptoms can be monitored for symptoms that could merit testing for the virus as well as “trigger additional treatment adjustments.”

In accordance with the IOIBD (International Organization for the Study of Inflammatory Bowel Disease) consensus, the update noted that IBD patients should continue going to infusion centers for therapies, provided that the centers use a COVID-19 screening protocol.

Patients with IBD who contract COVID-19 seem more likely to be hospitalized for one or the other disease, but that’s based on data from the international SECURE-IBD registry that had 164 patients as of the writing of the update. The update provides guidance for three scenarios for IBD patients during the pandemic:

• Patients not infected with SARS-CoV-2 should maintain their IBD therapies to sustain remission and avoid relapses. “Aside from the obvious negative consequences of a relapse, relapsing IBD will strain available medical resources, may require steroid therapy or necessitate hospitalization, outcomes that are all much worse than the known risks of existing IBD therapies,” Dr. Rubin and colleagues noted.
• Patients who are infected but have no symptoms of COVID-19 should have their dosing of prednisone adjusted to less than 20 mg/day or switched to budesonide; suspend thiopurines, methotrexate, and tofacitinib; and delay dosing of monoclonal antibodies (anti–tumor necrosis factor [anti-TNF] drugs, ustekinumab, or vedolizumab) for 2 weeks while their symptoms for COVID-19 are monitored. “Restarting therapy after 2 weeks if the patient has not developed manifestations of COVID-19 is reasonable,” wrote Dr. Rubin and colleagues. Emerging serial testing should indicate antibody status, but the effectiveness of stool testing for SARS-CoV-2 in these cases “remains to be seen.”
• In the patient with confirmed COVID-19, adjustment of IBD therapy “is appropriate, based on the understanding of the immune activity of the therapy and whether that therapy may worsen outcomes with COVID-19,” the update stated. Therapy adjustment should focus on reducing immune suppression during the active viral infection. Some studies are evaluating anticytokine-based therapies as COVID-19 treatments, so continued anti-TNF therapies might prevent acute respiratory distress syndrome and multiorgan failure, Dr. Rubin and colleagues wrote. “However, in the absence of those data, guidance is currently based on deciding whether to hold or to continue specific IBD therapies.”

The update considers most IBD therapies, specifically aminosalicylates, topical rectal therapy, dietary management, and antibiotics “safe and may be continued,” and oral budesonide can be continued if it’s needed for ongoing IBD control. However, corticosteroids “should be avoided and discontinued quickly.”

Likewise, during the acute stage of COVID-19, thiopurines, methotrexate, and tofacitinib should be discontinued, and anti-TNF drugs and ustekinumab should be stopped during viral illness. Holding vedolizumab during viral illness is also appropriate, according to the update, although the IOIBD group was uncertain if doing so was necessary.

If the IBD patient has digestive symptoms with COVID-19, ongoing supportive care of the COVID-19 is “reasonable,” but investigating the causes of the digestive symptoms “is critically important.” That should include ruling out enteric infections and confirming active inflammation with nonendoscopic testing. Endoscopy should be relegated to only urgent and emergent cases.

Management of IBD in COVID-19 patients also depends on disease severity. Safer therapies are indicated for mild disease, but withholding IBD therapy in moderate to severe cases may not be practical. “In this setting, the risks and benefits of escalating IBD therapy must be carefully weighed against the severity of the COVID-19,” Dr. Rubin and colleagues noted.

In hospitalized patients with severe COVID-19 and poor prognoses, “IBD therapy will likely take a back seat,” the update stated, although COVID-19 therapies should take the concomitant IBD into account. In patients with milder cases of COVID-19, IBD management should focus on acute manifestations, but intravenous steroid therapy shouldn’t exceed 3 days. The update urged providers to submit cases of IBD and confirmed COVID-19 to the SECURE-IBD registry at COVIDIBD.org.

Dr. Rubin disclosed financial relationships with AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene/Syneos, Gilead Sciences, Takeda, and many other pharmaceutical companies. Coauthors disclosed relationships with those companies and Medimmune, Novus Therapeutics, Osiris Therapeutics, RedHill Biopharma, Sanofi-Aventis, UCB Pharma, and multiple other pharmaceutical companies.

SOURCE: Rubin DT, et al. Gastroenterology. 2020:  doi: 10.1053/j.gastro.2020.04.012

Among women without celiac disease, dietary gluten intake was not associated with the risk of developing either Crohn’s disease or ulcerative colitis, investigators reported.

The findings spanned subgroups stratified by age, body mass index, smoking status, and whether individuals primarily consumed refined or whole grains, said Emily Walsh Lopes, MD, gastroenterology clinical and research fellow at Massachusetts General Hospital in Boston. She and associates reported the combined analysis of the prospective Nurses’ Health Study and Nurses’ Health Study II in an abstract released as part of the annual Digestive Disease Week.^®

“Avoidance of dietary gluten is common, and many patients attribute gastrointestinal symptoms to gluten intake,” Dr. Lopes said in an interview. “Though our findings warrant further study, the results suggest to patients and providers that eating gluten does not increase a person’s chance of getting diagnosed with inflammatory bowel disease.”

Prior studies have found that many individuals with inflammatory bowel disease avoid gluten and report subsequent improvements in gastrointestinal symptoms, even if they do not have celiac disease. However, it remains unclear whether dietary gluten is a risk factor for new-onset inflammatory bowel disease.

To address this question, Dr. Lopes and associates analyzed data collected from 165,327 women who took part in the Nurses’ Health Study (1986 to 2016) or the Nurses’ Health Study II (1991 through 2017). None of the women had a preexisting diagnosis of celiac disease or inflammatory bowel disease. Dietary gluten intake was estimated based on food frequency questionnaires completed by the women at baseline and every 4 years. The researchers also reviewed medical records to confirm self-reported cases of new-onset ulcerative colitis and Crohn’s disease.

Over 4.02 million person-years of follow-up, 277 women developed Crohn’s disease and 359 developed ulcerative colitis. Gluten intake was not associated with the risk of either type of inflammatory bowel disease, even after the researchers controlled for multiple demographic and clinical risk factors.

After submitting their abstract, Dr. Lopes and coinvestigators expanded the dataset to include a large cohort of men from the prospective Health Professionals Follow-up Study. The final pooled cohort included more than 208,000 women and men followed for more than 20 years. Through the end of follow-up, the researchers documented 337 cases of Crohn’s disease and 446 cases of ulcerative colitis. “Inclusion of the male cohort in the pooled analysis did not materially change our estimates,” Dr. Lopes told MDedge. “That is, no association was seen between gluten intake and risk of either Crohn’s disease or ulcerative colitis in the final cohort.”

She noted that the findings cannot be extrapolated to individuals who are already diagnosed with inflammatory bowel disease. “It is possible that different mechanisms exist to explain how gluten intake impacts those already diagnosed with IBD, and this topic warrants further study,” she said. Also, because the three cohort studies were observational, they are subject to bias. “While we tried to account for this in our analyses, residual bias may still exist.”

Dr. Lopes reported having no conflicts of interest.

SOURCE: Walsh Lopes E et al. DDW 2020, abstract 847.

Among women without celiac disease, dietary gluten intake was not associated with the risk of developing either Crohn’s disease or ulcerative colitis, investigators reported.

The findings spanned subgroups stratified by age, body mass index, smoking status, and whether individuals primarily consumed refined or whole grains, said Emily Walsh Lopes, MD, gastroenterology clinical and research fellow at Massachusetts General Hospital in Boston. She and associates reported the combined analysis of the prospective Nurses’ Health Study and Nurses’ Health Study II in an abstract released as part of the annual Digestive Disease Week.^®

“Avoidance of dietary gluten is common, and many patients attribute gastrointestinal symptoms to gluten intake,” Dr. Lopes said in an interview. “Though our findings warrant further study, the results suggest to patients and providers that eating gluten does not increase a person’s chance of getting diagnosed with inflammatory bowel disease.”

Prior studies have found that many individuals with inflammatory bowel disease avoid gluten and report subsequent improvements in gastrointestinal symptoms, even if they do not have celiac disease. However, it remains unclear whether dietary gluten is a risk factor for new-onset inflammatory bowel disease.

To address this question, Dr. Lopes and associates analyzed data collected from 165,327 women who took part in the Nurses’ Health Study (1986 to 2016) or the Nurses’ Health Study II (1991 through 2017). None of the women had a preexisting diagnosis of celiac disease or inflammatory bowel disease. Dietary gluten intake was estimated based on food frequency questionnaires completed by the women at baseline and every 4 years. The researchers also reviewed medical records to confirm self-reported cases of new-onset ulcerative colitis and Crohn’s disease.

Over 4.02 million person-years of follow-up, 277 women developed Crohn’s disease and 359 developed ulcerative colitis. Gluten intake was not associated with the risk of either type of inflammatory bowel disease, even after the researchers controlled for multiple demographic and clinical risk factors.

After submitting their abstract, Dr. Lopes and coinvestigators expanded the dataset to include a large cohort of men from the prospective Health Professionals Follow-up Study. The final pooled cohort included more than 208,000 women and men followed for more than 20 years. Through the end of follow-up, the researchers documented 337 cases of Crohn’s disease and 446 cases of ulcerative colitis. “Inclusion of the male cohort in the pooled analysis did not materially change our estimates,” Dr. Lopes told MDedge. “That is, no association was seen between gluten intake and risk of either Crohn’s disease or ulcerative colitis in the final cohort.”

She noted that the findings cannot be extrapolated to individuals who are already diagnosed with inflammatory bowel disease. “It is possible that different mechanisms exist to explain how gluten intake impacts those already diagnosed with IBD, and this topic warrants further study,” she said. Also, because the three cohort studies were observational, they are subject to bias. “While we tried to account for this in our analyses, residual bias may still exist.”

Dr. Lopes reported having no conflicts of interest.

SOURCE: Walsh Lopes E et al. DDW 2020, abstract 847.

Among women without celiac disease, dietary gluten intake was not associated with the risk of developing either Crohn’s disease or ulcerative colitis, investigators reported.

The findings spanned subgroups stratified by age, body mass index, smoking status, and whether individuals primarily consumed refined or whole grains, said Emily Walsh Lopes, MD, gastroenterology clinical and research fellow at Massachusetts General Hospital in Boston. She and associates reported the combined analysis of the prospective Nurses’ Health Study and Nurses’ Health Study II in an abstract released as part of the annual Digestive Disease Week.^®

“Avoidance of dietary gluten is common, and many patients attribute gastrointestinal symptoms to gluten intake,” Dr. Lopes said in an interview. “Though our findings warrant further study, the results suggest to patients and providers that eating gluten does not increase a person’s chance of getting diagnosed with inflammatory bowel disease.”

Prior studies have found that many individuals with inflammatory bowel disease avoid gluten and report subsequent improvements in gastrointestinal symptoms, even if they do not have celiac disease. However, it remains unclear whether dietary gluten is a risk factor for new-onset inflammatory bowel disease.

To address this question, Dr. Lopes and associates analyzed data collected from 165,327 women who took part in the Nurses’ Health Study (1986 to 2016) or the Nurses’ Health Study II (1991 through 2017). None of the women had a preexisting diagnosis of celiac disease or inflammatory bowel disease. Dietary gluten intake was estimated based on food frequency questionnaires completed by the women at baseline and every 4 years. The researchers also reviewed medical records to confirm self-reported cases of new-onset ulcerative colitis and Crohn’s disease.

Over 4.02 million person-years of follow-up, 277 women developed Crohn’s disease and 359 developed ulcerative colitis. Gluten intake was not associated with the risk of either type of inflammatory bowel disease, even after the researchers controlled for multiple demographic and clinical risk factors.

After submitting their abstract, Dr. Lopes and coinvestigators expanded the dataset to include a large cohort of men from the prospective Health Professionals Follow-up Study. The final pooled cohort included more than 208,000 women and men followed for more than 20 years. Through the end of follow-up, the researchers documented 337 cases of Crohn’s disease and 446 cases of ulcerative colitis. “Inclusion of the male cohort in the pooled analysis did not materially change our estimates,” Dr. Lopes told MDedge. “That is, no association was seen between gluten intake and risk of either Crohn’s disease or ulcerative colitis in the final cohort.”

She noted that the findings cannot be extrapolated to individuals who are already diagnosed with inflammatory bowel disease. “It is possible that different mechanisms exist to explain how gluten intake impacts those already diagnosed with IBD, and this topic warrants further study,” she said. Also, because the three cohort studies were observational, they are subject to bias. “While we tried to account for this in our analyses, residual bias may still exist.”

Dr. Lopes reported having no conflicts of interest.

SOURCE: Walsh Lopes E et al. DDW 2020, abstract 847.

For patients with inflammatory bowel disease (IBD) who develop coronavirus disease of 2019 (COVID-19), corticosteroid use may significantly increase risk of severe disease, according to data from more than 500 patients.

Use of sulfasalazine or 5-aminosalicylates (5-ASAs) also increased risk of severe COVID-19, albeit to a lesser degree, reported co-lead authors Erica J. Brenner, MD, of University of North Carolina Children’s Hospital, Chapel Hill, and Ryan C. Ungaro, MD, of Icahn School of Medicine at Mount Sinai, New York, and colleagues.

In contrast, tumor necrosis factor (TNF) blockers were not an independent risk factor for severe COVID-19.

“As TNF antagonists are the most commonly prescribed biologic therapy for patients with IBD, these initial findings should be reassuring to the large number of patients receiving TNF antagonist therapy and support their continued use during this current pandemic,” the investigators wrote in Gastroenterology.

These conclusions were drawn from the Surveillance Epidemiology of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease (SECURE-IBD) database, a large registry actively collecting data from clinicians around the world.

In the present analysis, which involved 525 patients from 33 countries, the investigators searched for independent risk factors for severe COVID-19. Various factors were tested through multivariable regression, including age, comorbidities, usage of specific medications, and more.

The primary outcome was defined by a composite of hospitalization, ventilator use, or death, while secondary outcomes included a composite of hospitalization or death, as well as death alone.

The analysis revealed that patients receiving corticosteroids had an adjusted odds ratio of 6.87 (95% confidence interval, 2.30-20.51) for severe COVID-19, with increased risks also detected for both secondary outcomes. In contrast, TNF antagonist use was not significantly associated with the primary outcome; in fact, a possible protective effect was detected for hospitalization or death (aOR, 0.60; 95% CI, 0.38-0.96).

The investigators noted that the above findings aligned with extensive literature concerning infectious complications with corticosteroid use and “more recent commentary” surrounding TNF antagonists. Similarly, increased age and the presence of at least two comorbidities were each independently associated with increased risk of severe COVID-19, both of which are correlations that have been previously described.

But the threefold increased risk of severe COVID-19 associated with use of sulfasalazine or 5-ASAs (aOR, 3.14; 95% CI, 1.28-7.71) was a “surprising” finding, the investigators noted.

“In a direct comparison, we observed that 5-ASA/sulfasalazine–treated patients fared worse than those treated with TNF inhibitors,” the investigators wrote. “Although we cannot exclude unmeasured confounding, further exploration of biological mechanisms is warranted.”

David T. Rubin, MD, AGAF, of the University of Chicago agreed that the finding deserves further investigation, particularly since sulfasalazine and 5-ASAs represent the second most commonly prescribed medication class for IBD.

“The risk with 5-ASAs is of interest but not well explained by what we know about the safety or the mechanism of these therapies,” Dr. Rubin said. “Clearly, more work is needed.”

The risks associated with corticosteroids were particularly concerning, Dr. Rubin said, because 10%-20% of patients with IBD may be taking corticosteroids at any given time.

“Steroids are still the number one prescribed therapy for Crohn’s and colitis,” he said.

Still, Dr. Rubin advised against abrupt changes to drug regimens, especially if they are effectively controlling IBD.

“Patients should stay on their existing therapies and stay in remission,” Dr. Rubin said. “If you stop your therapies … you are more likely to relapse. When you relapse, you’re more likely to need steroids as a rescue therapy … or end up in the hospital, and those are not places we want you to be.”

Despite the risks associated with steroids and sulfasalazine/5-ASAs, Dr. Rubin had an optimistic take on the study, calling the findings “very reassuring” because they support continued usage of TNF inhibitors and other biologic agents during the pandemic. He also noted that the SECURE-IBD registry, which he has contributed to, represents “an extraordinary effort” from around the world.

“[This is] an unprecedented collaboration across a scale and timeframe that has really never been seen before in our field, and I would hazard a guess that it’s probably never been seen in most other fields right now,” he said.

Clinicians seeking more information about managing patients with IBD during the COVID-19 pandemic can find guidance in the recent AGA practice update, of which Dr. Rubin was the lead author. Clinicians who would like to contribute to the SECURE-IBD registry may do so at covidibd.org. The registry now includes more than 1,000 patients.

The study was funded by Clinical and Translational Science Award grants through Dr. Ungaro. The investigators disclosed relationships with Takeda, Janssen, Pfizer, and others. Dr. Rubin disclosed relationships with Gilead, Eli Lilly, Shire, and others.

Check out the AGA COVID-19 Resource Library for new clinical guidance, education, research and physician resources, including recent guidance on how to treat patients with IBD during the pandemic, at www.gastro.org/covid.

SOURCE: Brenner EJ et al. Gastroenterology. 2020 May 18. doi: 10.1053/j.gastro.2020.05.032.

For patients with inflammatory bowel disease (IBD) who develop coronavirus disease of 2019 (COVID-19), corticosteroid use may significantly increase risk of severe disease, according to data from more than 500 patients.

Use of sulfasalazine or 5-aminosalicylates (5-ASAs) also increased risk of severe COVID-19, albeit to a lesser degree, reported co-lead authors Erica J. Brenner, MD, of University of North Carolina Children’s Hospital, Chapel Hill, and Ryan C. Ungaro, MD, of Icahn School of Medicine at Mount Sinai, New York, and colleagues.

In contrast, tumor necrosis factor (TNF) blockers were not an independent risk factor for severe COVID-19.

“As TNF antagonists are the most commonly prescribed biologic therapy for patients with IBD, these initial findings should be reassuring to the large number of patients receiving TNF antagonist therapy and support their continued use during this current pandemic,” the investigators wrote in Gastroenterology.

These conclusions were drawn from the Surveillance Epidemiology of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease (SECURE-IBD) database, a large registry actively collecting data from clinicians around the world.

In the present analysis, which involved 525 patients from 33 countries, the investigators searched for independent risk factors for severe COVID-19. Various factors were tested through multivariable regression, including age, comorbidities, usage of specific medications, and more.

The primary outcome was defined by a composite of hospitalization, ventilator use, or death, while secondary outcomes included a composite of hospitalization or death, as well as death alone.

The analysis revealed that patients receiving corticosteroids had an adjusted odds ratio of 6.87 (95% confidence interval, 2.30-20.51) for severe COVID-19, with increased risks also detected for both secondary outcomes. In contrast, TNF antagonist use was not significantly associated with the primary outcome; in fact, a possible protective effect was detected for hospitalization or death (aOR, 0.60; 95% CI, 0.38-0.96).

The investigators noted that the above findings aligned with extensive literature concerning infectious complications with corticosteroid use and “more recent commentary” surrounding TNF antagonists. Similarly, increased age and the presence of at least two comorbidities were each independently associated with increased risk of severe COVID-19, both of which are correlations that have been previously described.

But the threefold increased risk of severe COVID-19 associated with use of sulfasalazine or 5-ASAs (aOR, 3.14; 95% CI, 1.28-7.71) was a “surprising” finding, the investigators noted.

“In a direct comparison, we observed that 5-ASA/sulfasalazine–treated patients fared worse than those treated with TNF inhibitors,” the investigators wrote. “Although we cannot exclude unmeasured confounding, further exploration of biological mechanisms is warranted.”

David T. Rubin, MD, AGAF, of the University of Chicago agreed that the finding deserves further investigation, particularly since sulfasalazine and 5-ASAs represent the second most commonly prescribed medication class for IBD.

“The risk with 5-ASAs is of interest but not well explained by what we know about the safety or the mechanism of these therapies,” Dr. Rubin said. “Clearly, more work is needed.”

The risks associated with corticosteroids were particularly concerning, Dr. Rubin said, because 10%-20% of patients with IBD may be taking corticosteroids at any given time.

“Steroids are still the number one prescribed therapy for Crohn’s and colitis,” he said.

Still, Dr. Rubin advised against abrupt changes to drug regimens, especially if they are effectively controlling IBD.

“Patients should stay on their existing therapies and stay in remission,” Dr. Rubin said. “If you stop your therapies … you are more likely to relapse. When you relapse, you’re more likely to need steroids as a rescue therapy … or end up in the hospital, and those are not places we want you to be.”

Despite the risks associated with steroids and sulfasalazine/5-ASAs, Dr. Rubin had an optimistic take on the study, calling the findings “very reassuring” because they support continued usage of TNF inhibitors and other biologic agents during the pandemic. He also noted that the SECURE-IBD registry, which he has contributed to, represents “an extraordinary effort” from around the world.

“[This is] an unprecedented collaboration across a scale and timeframe that has really never been seen before in our field, and I would hazard a guess that it’s probably never been seen in most other fields right now,” he said.

Clinicians seeking more information about managing patients with IBD during the COVID-19 pandemic can find guidance in the recent AGA practice update, of which Dr. Rubin was the lead author. Clinicians who would like to contribute to the SECURE-IBD registry may do so at covidibd.org. The registry now includes more than 1,000 patients.

The study was funded by Clinical and Translational Science Award grants through Dr. Ungaro. The investigators disclosed relationships with Takeda, Janssen, Pfizer, and others. Dr. Rubin disclosed relationships with Gilead, Eli Lilly, Shire, and others.

Check out the AGA COVID-19 Resource Library for new clinical guidance, education, research and physician resources, including recent guidance on how to treat patients with IBD during the pandemic, at www.gastro.org/covid.

SOURCE: Brenner EJ et al. Gastroenterology. 2020 May 18. doi: 10.1053/j.gastro.2020.05.032.

For patients with inflammatory bowel disease (IBD) who develop coronavirus disease of 2019 (COVID-19), corticosteroid use may significantly increase risk of severe disease, according to data from more than 500 patients.

Use of sulfasalazine or 5-aminosalicylates (5-ASAs) also increased risk of severe COVID-19, albeit to a lesser degree, reported co-lead authors Erica J. Brenner, MD, of University of North Carolina Children’s Hospital, Chapel Hill, and Ryan C. Ungaro, MD, of Icahn School of Medicine at Mount Sinai, New York, and colleagues.

In contrast, tumor necrosis factor (TNF) blockers were not an independent risk factor for severe COVID-19.

“As TNF antagonists are the most commonly prescribed biologic therapy for patients with IBD, these initial findings should be reassuring to the large number of patients receiving TNF antagonist therapy and support their continued use during this current pandemic,” the investigators wrote in Gastroenterology.

These conclusions were drawn from the Surveillance Epidemiology of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease (SECURE-IBD) database, a large registry actively collecting data from clinicians around the world.

In the present analysis, which involved 525 patients from 33 countries, the investigators searched for independent risk factors for severe COVID-19. Various factors were tested through multivariable regression, including age, comorbidities, usage of specific medications, and more.

The primary outcome was defined by a composite of hospitalization, ventilator use, or death, while secondary outcomes included a composite of hospitalization or death, as well as death alone.

The analysis revealed that patients receiving corticosteroids had an adjusted odds ratio of 6.87 (95% confidence interval, 2.30-20.51) for severe COVID-19, with increased risks also detected for both secondary outcomes. In contrast, TNF antagonist use was not significantly associated with the primary outcome; in fact, a possible protective effect was detected for hospitalization or death (aOR, 0.60; 95% CI, 0.38-0.96).

The investigators noted that the above findings aligned with extensive literature concerning infectious complications with corticosteroid use and “more recent commentary” surrounding TNF antagonists. Similarly, increased age and the presence of at least two comorbidities were each independently associated with increased risk of severe COVID-19, both of which are correlations that have been previously described.

But the threefold increased risk of severe COVID-19 associated with use of sulfasalazine or 5-ASAs (aOR, 3.14; 95% CI, 1.28-7.71) was a “surprising” finding, the investigators noted.

“In a direct comparison, we observed that 5-ASA/sulfasalazine–treated patients fared worse than those treated with TNF inhibitors,” the investigators wrote. “Although we cannot exclude unmeasured confounding, further exploration of biological mechanisms is warranted.”

David T. Rubin, MD, AGAF, of the University of Chicago agreed that the finding deserves further investigation, particularly since sulfasalazine and 5-ASAs represent the second most commonly prescribed medication class for IBD.

“The risk with 5-ASAs is of interest but not well explained by what we know about the safety or the mechanism of these therapies,” Dr. Rubin said. “Clearly, more work is needed.”

The risks associated with corticosteroids were particularly concerning, Dr. Rubin said, because 10%-20% of patients with IBD may be taking corticosteroids at any given time.

“Steroids are still the number one prescribed therapy for Crohn’s and colitis,” he said.

Still, Dr. Rubin advised against abrupt changes to drug regimens, especially if they are effectively controlling IBD.

“Patients should stay on their existing therapies and stay in remission,” Dr. Rubin said. “If you stop your therapies … you are more likely to relapse. When you relapse, you’re more likely to need steroids as a rescue therapy … or end up in the hospital, and those are not places we want you to be.”

Despite the risks associated with steroids and sulfasalazine/5-ASAs, Dr. Rubin had an optimistic take on the study, calling the findings “very reassuring” because they support continued usage of TNF inhibitors and other biologic agents during the pandemic. He also noted that the SECURE-IBD registry, which he has contributed to, represents “an extraordinary effort” from around the world.

“[This is] an unprecedented collaboration across a scale and timeframe that has really never been seen before in our field, and I would hazard a guess that it’s probably never been seen in most other fields right now,” he said.

Clinicians seeking more information about managing patients with IBD during the COVID-19 pandemic can find guidance in the recent AGA practice update, of which Dr. Rubin was the lead author. Clinicians who would like to contribute to the SECURE-IBD registry may do so at covidibd.org. The registry now includes more than 1,000 patients.

The study was funded by Clinical and Translational Science Award grants through Dr. Ungaro. The investigators disclosed relationships with Takeda, Janssen, Pfizer, and others. Dr. Rubin disclosed relationships with Gilead, Eli Lilly, Shire, and others.

Check out the AGA COVID-19 Resource Library for new clinical guidance, education, research and physician resources, including recent guidance on how to treat patients with IBD during the pandemic, at www.gastro.org/covid.

SOURCE: Brenner EJ et al. Gastroenterology. 2020 May 18. doi: 10.1053/j.gastro.2020.05.032.

Gastrointestinal symptoms affected 26% of hospital employees hospitalized with presumptive COVID-19 infection, according to the results of a study from Wuhan, China.

Among nonmedical personnel in the study (median age, 62 years), 63% of those with GI symptoms were female (P = .03), wrote Zili Zhou of Huazhong University of Science and Technology, Wuhan, China, and associates. Gastrointestinal symptoms correlated significantly with lower hemoglobin levels, increased levels of inflammatory markers, and poorer liver function, but not with clinical complications or mortality, they noted. However, “most patients were still hospitalized at the time of [manuscript] submission, [which made it] difficult to further assess the correlation between GI symptoms and clinical outcomes,” they wrote in Gastroenterology.

Reverse transcriptase polymerase chain reaction has detected COVID-19 in patients’ stool, and COVID-19’s primary receptor for cellular entry, the angiotensin converting enzyme 2 (ACE2) receptor, “is highly expressed not only in lung AT2 cells but also in absorptive enterocytes in the ileum and colon,” the investigators wrote. They compared laboratory and clinical findings among 254 adults with and without GI symptoms who were admitted to Wuhan’s main hospital with presumptive COVID-19 pneumonia between December 20, 2019, and February 9, 2020. All patients were employed by the hospital.

Gastrointestinal symptoms affected 26% of patients and most commonly included diarrhea (18%), nausea (8%), vomiting (6%), and abdominal pain (2%), the researchers reported. Arrhythmias and shock were rare, affecting less than 0.5% of patients. A total of 16 patients (6%) died.

The 161 nonmedical staff in the study were older and, therefore, were evaluated separately from medical staff (respective medians, 36 and 62 years; interquartile ranges, 31-41 years and 49-69 years). Among nonmedical staff, GI symptoms correlated with significantly lower hemoglobin levels (117 g/L [range, 106-127] vs. 133 g/L [range, 114-141], P = .03), and significantly higher levels of C-reactive protein (7.3 mg [range, 2.9-6.6] vs. 3.8 mg (1.8-5.8), P = .021) and alanine aminotransferase (64.1 U/L [range, 51.2-64.4] vs. 46.6 U/L [range, 31.9-61.2]; P = .049). Gastrointestinal symptoms also correlated significantly with fatigue, sore throat, and dizziness. Although the nonmedical cohort included five more males than females, females made up nearly two-thirds (63%) of individuals with GI symptoms (P = .03).

Although 25% of medical staff in the study had GI symptoms, GI symptoms did not correlate with other symptoms or with laboratory findings. This might be because “most of the infected medical staff were younger nurses without comorbidities,” the investigators wrote. “In addition, there [was] less delay from the onset of symptoms to hospital admission.”

For the overall cohort, the most prevalent symptoms were fever (84%), fatigue (52%), productive cough (42%), dry cough (42%), and myalgia (34%). Although these symptoms are typical of COVID-19 infection, most patients were not tested for the virus, “which will inevitably lead to several patients without [COVID-19 pneumonia] being included,” the investigators noted.

The National Nature Science Foundation of China provided funding. The investigators reported having no relevant conflicts of interest.

SOURCE: Zhou Z et al. Gastroenterology. 2020 Mar 18. doi: 10.1053/j.gastro.2020.03.020.

Gastrointestinal symptoms affected 26% of hospital employees hospitalized with presumptive COVID-19 infection, according to the results of a study from Wuhan, China.

Among nonmedical personnel in the study (median age, 62 years), 63% of those with GI symptoms were female (P = .03), wrote Zili Zhou of Huazhong University of Science and Technology, Wuhan, China, and associates. Gastrointestinal symptoms correlated significantly with lower hemoglobin levels, increased levels of inflammatory markers, and poorer liver function, but not with clinical complications or mortality, they noted. However, “most patients were still hospitalized at the time of [manuscript] submission, [which made it] difficult to further assess the correlation between GI symptoms and clinical outcomes,” they wrote in Gastroenterology.

Reverse transcriptase polymerase chain reaction has detected COVID-19 in patients’ stool, and COVID-19’s primary receptor for cellular entry, the angiotensin converting enzyme 2 (ACE2) receptor, “is highly expressed not only in lung AT2 cells but also in absorptive enterocytes in the ileum and colon,” the investigators wrote. They compared laboratory and clinical findings among 254 adults with and without GI symptoms who were admitted to Wuhan’s main hospital with presumptive COVID-19 pneumonia between December 20, 2019, and February 9, 2020. All patients were employed by the hospital.

Gastrointestinal symptoms affected 26% of patients and most commonly included diarrhea (18%), nausea (8%), vomiting (6%), and abdominal pain (2%), the researchers reported. Arrhythmias and shock were rare, affecting less than 0.5% of patients. A total of 16 patients (6%) died.

The 161 nonmedical staff in the study were older and, therefore, were evaluated separately from medical staff (respective medians, 36 and 62 years; interquartile ranges, 31-41 years and 49-69 years). Among nonmedical staff, GI symptoms correlated with significantly lower hemoglobin levels (117 g/L [range, 106-127] vs. 133 g/L [range, 114-141], P = .03), and significantly higher levels of C-reactive protein (7.3 mg [range, 2.9-6.6] vs. 3.8 mg (1.8-5.8), P = .021) and alanine aminotransferase (64.1 U/L [range, 51.2-64.4] vs. 46.6 U/L [range, 31.9-61.2]; P = .049). Gastrointestinal symptoms also correlated significantly with fatigue, sore throat, and dizziness. Although the nonmedical cohort included five more males than females, females made up nearly two-thirds (63%) of individuals with GI symptoms (P = .03).

Although 25% of medical staff in the study had GI symptoms, GI symptoms did not correlate with other symptoms or with laboratory findings. This might be because “most of the infected medical staff were younger nurses without comorbidities,” the investigators wrote. “In addition, there [was] less delay from the onset of symptoms to hospital admission.”

For the overall cohort, the most prevalent symptoms were fever (84%), fatigue (52%), productive cough (42%), dry cough (42%), and myalgia (34%). Although these symptoms are typical of COVID-19 infection, most patients were not tested for the virus, “which will inevitably lead to several patients without [COVID-19 pneumonia] being included,” the investigators noted.

The National Nature Science Foundation of China provided funding. The investigators reported having no relevant conflicts of interest.

SOURCE: Zhou Z et al. Gastroenterology. 2020 Mar 18. doi: 10.1053/j.gastro.2020.03.020.

Gastrointestinal symptoms affected 26% of hospital employees hospitalized with presumptive COVID-19 infection, according to the results of a study from Wuhan, China.

Among nonmedical personnel in the study (median age, 62 years), 63% of those with GI symptoms were female (P = .03), wrote Zili Zhou of Huazhong University of Science and Technology, Wuhan, China, and associates. Gastrointestinal symptoms correlated significantly with lower hemoglobin levels, increased levels of inflammatory markers, and poorer liver function, but not with clinical complications or mortality, they noted. However, “most patients were still hospitalized at the time of [manuscript] submission, [which made it] difficult to further assess the correlation between GI symptoms and clinical outcomes,” they wrote in Gastroenterology.

Reverse transcriptase polymerase chain reaction has detected COVID-19 in patients’ stool, and COVID-19’s primary receptor for cellular entry, the angiotensin converting enzyme 2 (ACE2) receptor, “is highly expressed not only in lung AT2 cells but also in absorptive enterocytes in the ileum and colon,” the investigators wrote. They compared laboratory and clinical findings among 254 adults with and without GI symptoms who were admitted to Wuhan’s main hospital with presumptive COVID-19 pneumonia between December 20, 2019, and February 9, 2020. All patients were employed by the hospital.

Gastrointestinal symptoms affected 26% of patients and most commonly included diarrhea (18%), nausea (8%), vomiting (6%), and abdominal pain (2%), the researchers reported. Arrhythmias and shock were rare, affecting less than 0.5% of patients. A total of 16 patients (6%) died.

The 161 nonmedical staff in the study were older and, therefore, were evaluated separately from medical staff (respective medians, 36 and 62 years; interquartile ranges, 31-41 years and 49-69 years). Among nonmedical staff, GI symptoms correlated with significantly lower hemoglobin levels (117 g/L [range, 106-127] vs. 133 g/L [range, 114-141], P = .03), and significantly higher levels of C-reactive protein (7.3 mg [range, 2.9-6.6] vs. 3.8 mg (1.8-5.8), P = .021) and alanine aminotransferase (64.1 U/L [range, 51.2-64.4] vs. 46.6 U/L [range, 31.9-61.2]; P = .049). Gastrointestinal symptoms also correlated significantly with fatigue, sore throat, and dizziness. Although the nonmedical cohort included five more males than females, females made up nearly two-thirds (63%) of individuals with GI symptoms (P = .03).

Although 25% of medical staff in the study had GI symptoms, GI symptoms did not correlate with other symptoms or with laboratory findings. This might be because “most of the infected medical staff were younger nurses without comorbidities,” the investigators wrote. “In addition, there [was] less delay from the onset of symptoms to hospital admission.”

For the overall cohort, the most prevalent symptoms were fever (84%), fatigue (52%), productive cough (42%), dry cough (42%), and myalgia (34%). Although these symptoms are typical of COVID-19 infection, most patients were not tested for the virus, “which will inevitably lead to several patients without [COVID-19 pneumonia] being included,” the investigators noted.

The National Nature Science Foundation of China provided funding. The investigators reported having no relevant conflicts of interest.

SOURCE: Zhou Z et al. Gastroenterology. 2020 Mar 18. doi: 10.1053/j.gastro.2020.03.020.

Children whose parents are coping with illness and injuries were more likely to need medical treatment and prescriptions for gastrointestinal conditions, for which previous research already has indicated a brain-gut connection, an investigator said.

In a self-controlled case series using records from the Military Health System Data Repository, pediatric visits for disorders linked to gut-brain interactions were found to have increased 9% (incidence rate ratio, 1.09; 95% CI, 1.07-1.10) following a parent’s illness or injury, reported lead author Patrick Short, MD, of the Uniformed Services University of the Health Sciences, Bethesda, Md., said in an interview. The Military Health System Data Repository receives records from the Department of Defense’s global network of more than 260 medical facilities as well as outside health care organizations where military families are seen.

A secondary analysis done for this study found children of brain injured parents had 4% more postinjury visits for abdominal pain and 23% increased odds of antispasmodic prescription, compared with children whose parents had other physical injuries, Dr. Short said. He presented his research in an abstract released as part of the annual Digestive Disease Week, which was canceled because of COVID-19. The study focused on children aged 3-16 years with a parent who served in the military and was ill or injured between 2004 and 2014. Excluded from this research were records for children with diagnosed systemic or organic gastrointestinal disease, such as celiac disease.

The study used ICD-9 codes to identify outpatient visits for irritable bowel syndrome, abdominal pain, constipation, and fecal incontinence in the 2 years before and after parental injury or diagnosis of illness. Outpatient pharmacy records showed which of the children studied took laxatives and antispasmodics.

Parental injury or illness was defined by the placement of the children’s mothers and fathers on the injured, ill, or wounded file in the data repository. The data file generally covers people with conditions that severely limit their ability to do their usual jobs. These include traumatic brain injury, PTSD, amputation, shrapnel injury, and illnesses such as cancer.

There was a 7% increase in visits for constipation but fecal incontinence did not significantly change following parental illness or injury, Dr. Short said. But the odds of being prescribed an antispasmodic increased 23% following parents’ injuries and serious illnesses, while the odds for laxative prescription decreased by 5%.

The study highlights the potential physical impact of stress on children when families experience a crisis, Dr. Short said in an interview. Children may feel anxious about their parent’s health, while at the same time experiencing unavoidable disruption in family life because of an injury or illness.

“It impacts the day-to-day regimens and routines and decreases the family support,” Dr. Short said. “As humans we are limited in what we have to offer. When we are trying to take care of things on our own, it limits what we can give to people around us.”

The findings of this study should serve to remind physicians to alert parents that their children could experience worsening of GI conditions because of the stress of an ill or injured parent. They then can focus on securing help ahead of the time for the child, such as therapy, he said.

The next step in advancing on the research he prepared for DDW could be testing through prospective studies how well preventive measures such as family counseling work, Dr. Short said.

Dr. Short’s research adds to the growing body of evidence about the brain-gut connection, said Kara Gross Margolis, MD, a spokesperson for the American Gastroenterological Association. An associate professor of pediatrics at Columbia University Medical Center, New York, Dr. Margolis has published research on the brain-gut axis. Her lab focuses on the effects of neurotransmitters and inflammation on enteric nervous system development and function.

Physicians should take a broad view when treating children for functional GI illnesses. Behavioral therapy and antidepressants, for example, have been shown to help children with conditions such as irritable bowel syndrome and other functional gastrointestinal diseases, said Dr. Margolis.

“In a number of these cases, we not only have to treat the gut. We have to treat the brain as well,” Dr. Margolis said.

“When mental health issues are involved that impact the parents of these kids, You have to look at a family as an entire unit,” she added. “You not only treat the child for those symptoms, but you really have to look at how their parents can also be cared for so that their impact on their children will be positive as well.”

Research in the vein explored by Dr. Short will be important to remember as society works through the legacy of the COVID-19 pandemic, Dr. Margolis said. “We have huge numbers of families undergoing tremendous stress due to loss of jobs, health care, medical issues, and parental injury potentially from coronavirus.”

No outside funding was reported, and the study was covered through Uniformed Services University budget.

SOURCE: Short P et al. DDW 2020, Abstract 815.

Children whose parents are coping with illness and injuries were more likely to need medical treatment and prescriptions for gastrointestinal conditions, for which previous research already has indicated a brain-gut connection, an investigator said.

In a self-controlled case series using records from the Military Health System Data Repository, pediatric visits for disorders linked to gut-brain interactions were found to have increased 9% (incidence rate ratio, 1.09; 95% CI, 1.07-1.10) following a parent’s illness or injury, reported lead author Patrick Short, MD, of the Uniformed Services University of the Health Sciences, Bethesda, Md., said in an interview. The Military Health System Data Repository receives records from the Department of Defense’s global network of more than 260 medical facilities as well as outside health care organizations where military families are seen.

A secondary analysis done for this study found children of brain injured parents had 4% more postinjury visits for abdominal pain and 23% increased odds of antispasmodic prescription, compared with children whose parents had other physical injuries, Dr. Short said. He presented his research in an abstract released as part of the annual Digestive Disease Week, which was canceled because of COVID-19. The study focused on children aged 3-16 years with a parent who served in the military and was ill or injured between 2004 and 2014. Excluded from this research were records for children with diagnosed systemic or organic gastrointestinal disease, such as celiac disease.

The study used ICD-9 codes to identify outpatient visits for irritable bowel syndrome, abdominal pain, constipation, and fecal incontinence in the 2 years before and after parental injury or diagnosis of illness. Outpatient pharmacy records showed which of the children studied took laxatives and antispasmodics.

Parental injury or illness was defined by the placement of the children’s mothers and fathers on the injured, ill, or wounded file in the data repository. The data file generally covers people with conditions that severely limit their ability to do their usual jobs. These include traumatic brain injury, PTSD, amputation, shrapnel injury, and illnesses such as cancer.

There was a 7% increase in visits for constipation but fecal incontinence did not significantly change following parental illness or injury, Dr. Short said. But the odds of being prescribed an antispasmodic increased 23% following parents’ injuries and serious illnesses, while the odds for laxative prescription decreased by 5%.

The study highlights the potential physical impact of stress on children when families experience a crisis, Dr. Short said in an interview. Children may feel anxious about their parent’s health, while at the same time experiencing unavoidable disruption in family life because of an injury or illness.

“It impacts the day-to-day regimens and routines and decreases the family support,” Dr. Short said. “As humans we are limited in what we have to offer. When we are trying to take care of things on our own, it limits what we can give to people around us.”

The findings of this study should serve to remind physicians to alert parents that their children could experience worsening of GI conditions because of the stress of an ill or injured parent. They then can focus on securing help ahead of the time for the child, such as therapy, he said.

The next step in advancing on the research he prepared for DDW could be testing through prospective studies how well preventive measures such as family counseling work, Dr. Short said.

Dr. Short’s research adds to the growing body of evidence about the brain-gut connection, said Kara Gross Margolis, MD, a spokesperson for the American Gastroenterological Association. An associate professor of pediatrics at Columbia University Medical Center, New York, Dr. Margolis has published research on the brain-gut axis. Her lab focuses on the effects of neurotransmitters and inflammation on enteric nervous system development and function.

Physicians should take a broad view when treating children for functional GI illnesses. Behavioral therapy and antidepressants, for example, have been shown to help children with conditions such as irritable bowel syndrome and other functional gastrointestinal diseases, said Dr. Margolis.

“In a number of these cases, we not only have to treat the gut. We have to treat the brain as well,” Dr. Margolis said.

“When mental health issues are involved that impact the parents of these kids, You have to look at a family as an entire unit,” she added. “You not only treat the child for those symptoms, but you really have to look at how their parents can also be cared for so that their impact on their children will be positive as well.”

Research in the vein explored by Dr. Short will be important to remember as society works through the legacy of the COVID-19 pandemic, Dr. Margolis said. “We have huge numbers of families undergoing tremendous stress due to loss of jobs, health care, medical issues, and parental injury potentially from coronavirus.”

No outside funding was reported, and the study was covered through Uniformed Services University budget.

SOURCE: Short P et al. DDW 2020, Abstract 815.

Children whose parents are coping with illness and injuries were more likely to need medical treatment and prescriptions for gastrointestinal conditions, for which previous research already has indicated a brain-gut connection, an investigator said.

In a self-controlled case series using records from the Military Health System Data Repository, pediatric visits for disorders linked to gut-brain interactions were found to have increased 9% (incidence rate ratio, 1.09; 95% CI, 1.07-1.10) following a parent’s illness or injury, reported lead author Patrick Short, MD, of the Uniformed Services University of the Health Sciences, Bethesda, Md., said in an interview. The Military Health System Data Repository receives records from the Department of Defense’s global network of more than 260 medical facilities as well as outside health care organizations where military families are seen.

A secondary analysis done for this study found children of brain injured parents had 4% more postinjury visits for abdominal pain and 23% increased odds of antispasmodic prescription, compared with children whose parents had other physical injuries, Dr. Short said. He presented his research in an abstract released as part of the annual Digestive Disease Week, which was canceled because of COVID-19. The study focused on children aged 3-16 years with a parent who served in the military and was ill or injured between 2004 and 2014. Excluded from this research were records for children with diagnosed systemic or organic gastrointestinal disease, such as celiac disease.

The study used ICD-9 codes to identify outpatient visits for irritable bowel syndrome, abdominal pain, constipation, and fecal incontinence in the 2 years before and after parental injury or diagnosis of illness. Outpatient pharmacy records showed which of the children studied took laxatives and antispasmodics.

Parental injury or illness was defined by the placement of the children’s mothers and fathers on the injured, ill, or wounded file in the data repository. The data file generally covers people with conditions that severely limit their ability to do their usual jobs. These include traumatic brain injury, PTSD, amputation, shrapnel injury, and illnesses such as cancer.

There was a 7% increase in visits for constipation but fecal incontinence did not significantly change following parental illness or injury, Dr. Short said. But the odds of being prescribed an antispasmodic increased 23% following parents’ injuries and serious illnesses, while the odds for laxative prescription decreased by 5%.

The study highlights the potential physical impact of stress on children when families experience a crisis, Dr. Short said in an interview. Children may feel anxious about their parent’s health, while at the same time experiencing unavoidable disruption in family life because of an injury or illness.

“It impacts the day-to-day regimens and routines and decreases the family support,” Dr. Short said. “As humans we are limited in what we have to offer. When we are trying to take care of things on our own, it limits what we can give to people around us.”

The findings of this study should serve to remind physicians to alert parents that their children could experience worsening of GI conditions because of the stress of an ill or injured parent. They then can focus on securing help ahead of the time for the child, such as therapy, he said.

The next step in advancing on the research he prepared for DDW could be testing through prospective studies how well preventive measures such as family counseling work, Dr. Short said.

Dr. Short’s research adds to the growing body of evidence about the brain-gut connection, said Kara Gross Margolis, MD, a spokesperson for the American Gastroenterological Association. An associate professor of pediatrics at Columbia University Medical Center, New York, Dr. Margolis has published research on the brain-gut axis. Her lab focuses on the effects of neurotransmitters and inflammation on enteric nervous system development and function.

Physicians should take a broad view when treating children for functional GI illnesses. Behavioral therapy and antidepressants, for example, have been shown to help children with conditions such as irritable bowel syndrome and other functional gastrointestinal diseases, said Dr. Margolis.

“In a number of these cases, we not only have to treat the gut. We have to treat the brain as well,” Dr. Margolis said.

“When mental health issues are involved that impact the parents of these kids, You have to look at a family as an entire unit,” she added. “You not only treat the child for those symptoms, but you really have to look at how their parents can also be cared for so that their impact on their children will be positive as well.”

Research in the vein explored by Dr. Short will be important to remember as society works through the legacy of the COVID-19 pandemic, Dr. Margolis said. “We have huge numbers of families undergoing tremendous stress due to loss of jobs, health care, medical issues, and parental injury potentially from coronavirus.”

No outside funding was reported, and the study was covered through Uniformed Services University budget.

SOURCE: Short P et al. DDW 2020, Abstract 815.

Antibiotic exposure within 14 days after screening colonoscopy may increase risk of irritable bowel syndrome (IBS), based on a retrospective analysis of more than 400,000 individuals.

Antibiotic use in the 2 weeks leading up to colonoscopy also trended toward an association with IBS, reported lead author Ravy Vajravelu, MD, of University of Pennsylvania, Philadelphia, and colleagues.

“Laboratory studies in mice have demonstrated that colon cleansing in conjunction with systemic antibiotic use can cause persistent intestinal dysbiosis,” the investigators wrote in an abstract released as part of the annual Digestive Disease Week®, which was canceled because of COVID-19. “Because perturbation of the gut microbiome is thought to be a trigger for the development of IBS, we sought to assess whether humans who undergo bowel cleanse for colonoscopy in conjunction with antibiotic exposure develop new-onset IBS or IBS-related symptoms.”

According to Dr. Vajravelu, previous human studies have shown that bowel cleansing or antibiotics can alter the baseline gut microbiome, but no previous human research explored the impact of both triggers at once.

The present study involved individuals 50 years or older from the OptumInsight Clinformatics database who underwent screening colonoscopy between 2000 and 2016. Those with preexisting gastrointestinal conditions or symptoms within 180 days leading up to colonoscopy were excluded, leaving 402,259 individuals in the final cohort. From this group, individuals were identified who had exposure to antibiotics within 14 days before and/or after colonoscopy.

The primary outcome was a diagnosis of IBS in the 180 days following the antibiotic exposure window. Secondary outcomes included newly diagnosed diarrhea, change in bowel habits, and abdominal pain. A variety of covariates were tested through multivariable logistical regression, including gastrointestinal infections, medical comorbidities, and demographic factors, with only sex and age remaining in the final model.

Across the cohort, 2% of patients received antibiotics either before or after colonoscopy, while 1% had exposure both before and after. A total of 1,002 individuals (0.2%) were diagnosed with IBS within a median time frame of 112 days.

Multivariate analysis revealed that individuals exposed to antibiotics in the 14 days following colonoscopy had a 77% increased risk of developing IBS (adjusted odds ratio, 1.77; 95% confidence interval, 1.31-2.39). To a lesser degree, and not quite achieving statistical significance, trends toward an association were found for antibiotic exposure before colonoscopy (aOR, 1.38; 95% CI, 0.99-1.92), and for antibiotic exposure both before and after colonoscopy (aOR, 1.41; 95% CI, 0.97-2.04).

Dr. Vajravelu said that these preliminary findings are currently undergoing further analysis.

“In particular, we are interested in determining whether antibiotics that target gram-negative bacteria, which are abundant in the gut, have a greater association with subsequent IBS,” Dr. Vajravelu said.

In addition, they are taking steps to eliminate other confounding factors.

“The main objective of these new analyses is to ensure that the association between bowel cleanse and antibiotics with subsequent IBS is not related to the reasons antibiotics were prescribed initially,” Dr. Vajravelu said. “For example, someone experiencing diarrhea could receive a trial of empiric antibiotics and then receive a colonoscopy when the diarrhea does not resolve. In [the present analysis], we avoided including individuals like this by including only those who underwent screening colonoscopy, and therefore did not have any prior documented GI symptoms. In our [ongoing] analyses, we are including additional restrictions to strengthen the findings.”

If the findings do hold, Dr. Vajravelu suggested that they may have clinical implications.

“[I]t may be important to review whether patients scheduled for colonoscopy have received recent antibiotics and warn them to avoid antibiotics after colonoscopy, if possible,” Dr. Vajravelu said. “Additionally, for gastroenterologists, these data may underscore the importance of adhering to preprocedural antibiotic prophylaxis guidelines put forth by GI societies.”The investigators disclosed relationships with Merck, Pfizer, Gilead, and others.

SOURCE: Vajravelu R et al. DDW 2020. Abstract 404.

Antibiotic exposure within 14 days after screening colonoscopy may increase risk of irritable bowel syndrome (IBS), based on a retrospective analysis of more than 400,000 individuals.

Antibiotic use in the 2 weeks leading up to colonoscopy also trended toward an association with IBS, reported lead author Ravy Vajravelu, MD, of University of Pennsylvania, Philadelphia, and colleagues.

“Laboratory studies in mice have demonstrated that colon cleansing in conjunction with systemic antibiotic use can cause persistent intestinal dysbiosis,” the investigators wrote in an abstract released as part of the annual Digestive Disease Week®, which was canceled because of COVID-19. “Because perturbation of the gut microbiome is thought to be a trigger for the development of IBS, we sought to assess whether humans who undergo bowel cleanse for colonoscopy in conjunction with antibiotic exposure develop new-onset IBS or IBS-related symptoms.”

According to Dr. Vajravelu, previous human studies have shown that bowel cleansing or antibiotics can alter the baseline gut microbiome, but no previous human research explored the impact of both triggers at once.

The present study involved individuals 50 years or older from the OptumInsight Clinformatics database who underwent screening colonoscopy between 2000 and 2016. Those with preexisting gastrointestinal conditions or symptoms within 180 days leading up to colonoscopy were excluded, leaving 402,259 individuals in the final cohort. From this group, individuals were identified who had exposure to antibiotics within 14 days before and/or after colonoscopy.

The primary outcome was a diagnosis of IBS in the 180 days following the antibiotic exposure window. Secondary outcomes included newly diagnosed diarrhea, change in bowel habits, and abdominal pain. A variety of covariates were tested through multivariable logistical regression, including gastrointestinal infections, medical comorbidities, and demographic factors, with only sex and age remaining in the final model.

Across the cohort, 2% of patients received antibiotics either before or after colonoscopy, while 1% had exposure both before and after. A total of 1,002 individuals (0.2%) were diagnosed with IBS within a median time frame of 112 days.

Multivariate analysis revealed that individuals exposed to antibiotics in the 14 days following colonoscopy had a 77% increased risk of developing IBS (adjusted odds ratio, 1.77; 95% confidence interval, 1.31-2.39). To a lesser degree, and not quite achieving statistical significance, trends toward an association were found for antibiotic exposure before colonoscopy (aOR, 1.38; 95% CI, 0.99-1.92), and for antibiotic exposure both before and after colonoscopy (aOR, 1.41; 95% CI, 0.97-2.04).

Dr. Vajravelu said that these preliminary findings are currently undergoing further analysis.

“In particular, we are interested in determining whether antibiotics that target gram-negative bacteria, which are abundant in the gut, have a greater association with subsequent IBS,” Dr. Vajravelu said.

In addition, they are taking steps to eliminate other confounding factors.

“The main objective of these new analyses is to ensure that the association between bowel cleanse and antibiotics with subsequent IBS is not related to the reasons antibiotics were prescribed initially,” Dr. Vajravelu said. “For example, someone experiencing diarrhea could receive a trial of empiric antibiotics and then receive a colonoscopy when the diarrhea does not resolve. In [the present analysis], we avoided including individuals like this by including only those who underwent screening colonoscopy, and therefore did not have any prior documented GI symptoms. In our [ongoing] analyses, we are including additional restrictions to strengthen the findings.”

If the findings do hold, Dr. Vajravelu suggested that they may have clinical implications.

“[I]t may be important to review whether patients scheduled for colonoscopy have received recent antibiotics and warn them to avoid antibiotics after colonoscopy, if possible,” Dr. Vajravelu said. “Additionally, for gastroenterologists, these data may underscore the importance of adhering to preprocedural antibiotic prophylaxis guidelines put forth by GI societies.”The investigators disclosed relationships with Merck, Pfizer, Gilead, and others.

SOURCE: Vajravelu R et al. DDW 2020. Abstract 404.

Antibiotic exposure within 14 days after screening colonoscopy may increase risk of irritable bowel syndrome (IBS), based on a retrospective analysis of more than 400,000 individuals.

Antibiotic use in the 2 weeks leading up to colonoscopy also trended toward an association with IBS, reported lead author Ravy Vajravelu, MD, of University of Pennsylvania, Philadelphia, and colleagues.

“Laboratory studies in mice have demonstrated that colon cleansing in conjunction with systemic antibiotic use can cause persistent intestinal dysbiosis,” the investigators wrote in an abstract released as part of the annual Digestive Disease Week®, which was canceled because of COVID-19. “Because perturbation of the gut microbiome is thought to be a trigger for the development of IBS, we sought to assess whether humans who undergo bowel cleanse for colonoscopy in conjunction with antibiotic exposure develop new-onset IBS or IBS-related symptoms.”

According to Dr. Vajravelu, previous human studies have shown that bowel cleansing or antibiotics can alter the baseline gut microbiome, but no previous human research explored the impact of both triggers at once.

The present study involved individuals 50 years or older from the OptumInsight Clinformatics database who underwent screening colonoscopy between 2000 and 2016. Those with preexisting gastrointestinal conditions or symptoms within 180 days leading up to colonoscopy were excluded, leaving 402,259 individuals in the final cohort. From this group, individuals were identified who had exposure to antibiotics within 14 days before and/or after colonoscopy.

The primary outcome was a diagnosis of IBS in the 180 days following the antibiotic exposure window. Secondary outcomes included newly diagnosed diarrhea, change in bowel habits, and abdominal pain. A variety of covariates were tested through multivariable logistical regression, including gastrointestinal infections, medical comorbidities, and demographic factors, with only sex and age remaining in the final model.

Across the cohort, 2% of patients received antibiotics either before or after colonoscopy, while 1% had exposure both before and after. A total of 1,002 individuals (0.2%) were diagnosed with IBS within a median time frame of 112 days.

Multivariate analysis revealed that individuals exposed to antibiotics in the 14 days following colonoscopy had a 77% increased risk of developing IBS (adjusted odds ratio, 1.77; 95% confidence interval, 1.31-2.39). To a lesser degree, and not quite achieving statistical significance, trends toward an association were found for antibiotic exposure before colonoscopy (aOR, 1.38; 95% CI, 0.99-1.92), and for antibiotic exposure both before and after colonoscopy (aOR, 1.41; 95% CI, 0.97-2.04).

Dr. Vajravelu said that these preliminary findings are currently undergoing further analysis.

“In particular, we are interested in determining whether antibiotics that target gram-negative bacteria, which are abundant in the gut, have a greater association with subsequent IBS,” Dr. Vajravelu said.

In addition, they are taking steps to eliminate other confounding factors.

“The main objective of these new analyses is to ensure that the association between bowel cleanse and antibiotics with subsequent IBS is not related to the reasons antibiotics were prescribed initially,” Dr. Vajravelu said. “For example, someone experiencing diarrhea could receive a trial of empiric antibiotics and then receive a colonoscopy when the diarrhea does not resolve. In [the present analysis], we avoided including individuals like this by including only those who underwent screening colonoscopy, and therefore did not have any prior documented GI symptoms. In our [ongoing] analyses, we are including additional restrictions to strengthen the findings.”

If the findings do hold, Dr. Vajravelu suggested that they may have clinical implications.

“[I]t may be important to review whether patients scheduled for colonoscopy have received recent antibiotics and warn them to avoid antibiotics after colonoscopy, if possible,” Dr. Vajravelu said. “Additionally, for gastroenterologists, these data may underscore the importance of adhering to preprocedural antibiotic prophylaxis guidelines put forth by GI societies.”The investigators disclosed relationships with Merck, Pfizer, Gilead, and others.

SOURCE: Vajravelu R et al. DDW 2020. Abstract 404.

Individuals who sleep more or less than average report significantly more constipation, compared with normal sleepers, based on data from 14,590 adults.

“Normal sleep duration is thought to be essential for healthy bowel function; however, the effect of either limited or excessive sleep duration on bowel patterns is poorly understood,” Adeyinka Adejumo, MD, of North Shore Medical Center, Salem, Mass., and colleagues wrote in an abstract released as part of the annual Digestive Disease Week^®, which was canceled because of COVID-19.

To examine the association between sleep duration and bowel function, the researchers identified 14,590 adults aged 20 years and older who completed questionnaires on sleep and bowel health as part of the National Health and Nutrition Examination Survey (NHANES) during 2005-2010.

Sleep was divided into three categories based on standards from the National Sleep Foundation: short (less than 7 hours), normal (7-8 hours) and long (more than 8 hours).

Overall, constipation rates were significantly lower among normal sleepers (8.3%) compared with both short and long sleepers (11.0% and 12.5%, respectively; P < .0001 for both).

Bowel function was defined as normal, constipation, or diarrhea based on stool form and bowel movements per week. After controlling for demographic, lifestyle, and dietary factors, long sleepers and short sleepers were 61% and 38% more likely, respectively, to report constipation, compared with normal sleepers.

However, sleep duration was not related to diarrhea, the researchers noted. In addition, “A sensitivity analysis revealed that sleep duration did not mediate the relationship between comorbid factors (such as overall health, poverty index, obesity, and body mass index) and constipation,” they wrote.

The results suggest that decreased sleep is associated with constipation among adults in the United States, the researchers said. However, “further studies are needed to evaluate the physiologic mechanisms driving the impact of sleep duration on bowel function to determine whether sleep disorders or their underlying causes affect constipation,” they concluded.

“This study was necessary because up to 50% of Americans suffer from sleep disorders, out of which abnormal sleep duration is one of the most common and underdiagnosed, and associated with other diseases such as hypertension and diabetes,” Dr. Adejumo said in an interview. “However, disorders of bowel function (constipation and diarrhea), which affect almost 10%-15% of the population and result in significant health care burden, such as higher cost, hospital visits, abdominal discomfort, have not been studied among individuals with suboptimal sleep duration.”

Dr. Adejumo said he and his colleagues were surprised by their findings. “Although, based on our hypothesis, we thought that sleeping too long may be associated with constipation, we were shocked to note similar results among people who also sleep for short durations,” he noted.

“Previous studies had suggested that bowel contraction slows down considerably during sleep. It, therefore, will make sense that sleeping for too long may result in suppressed bowel motility and decreased bowel movement,” he said. “However, our results showed similar findings among short sleepers. We do not know the exact mechanism of these results. It may be that short sleep resulted in inadequate bowel rest, bowel muscle fatigue, and, subsequently, decreased bowel movement,” said Dr. Adejumo. “Or it may also be that brain-gut signaling pathways are disrupted among short sleepers, as is seen among IBS patients after a poor night sleep, resulting in higher constipation,” he added.

Clinicians should be aware of the impact of both short and long sleep on constipation, said Dr. Adejumo. “Individuals who are unable to have adequate periods of sleep due to other diseases, including insomnia, disrupted job schedules, or conditions with too long sleep, such as narcolepsy, may all additionally suffer from constipation. Such patients may need regular evaluation and treatment for constipation to improve their discomfort,” he said.

“To confirm our findings, other clinical studies with more granular data on sleep and constipation, are needed, as well as translational research to uncover the potential mechanisms of these findings,” he emphasized.

The researchers had no financial conflicts to disclose.
 

SOURCE: Adejumo A et al. DDW 2020. Abstract Sa1711.

Individuals who sleep more or less than average report significantly more constipation, compared with normal sleepers, based on data from 14,590 adults.

“Normal sleep duration is thought to be essential for healthy bowel function; however, the effect of either limited or excessive sleep duration on bowel patterns is poorly understood,” Adeyinka Adejumo, MD, of North Shore Medical Center, Salem, Mass., and colleagues wrote in an abstract released as part of the annual Digestive Disease Week^®, which was canceled because of COVID-19.

To examine the association between sleep duration and bowel function, the researchers identified 14,590 adults aged 20 years and older who completed questionnaires on sleep and bowel health as part of the National Health and Nutrition Examination Survey (NHANES) during 2005-2010.

Sleep was divided into three categories based on standards from the National Sleep Foundation: short (less than 7 hours), normal (7-8 hours) and long (more than 8 hours).

Overall, constipation rates were significantly lower among normal sleepers (8.3%) compared with both short and long sleepers (11.0% and 12.5%, respectively; P < .0001 for both).

Bowel function was defined as normal, constipation, or diarrhea based on stool form and bowel movements per week. After controlling for demographic, lifestyle, and dietary factors, long sleepers and short sleepers were 61% and 38% more likely, respectively, to report constipation, compared with normal sleepers.

However, sleep duration was not related to diarrhea, the researchers noted. In addition, “A sensitivity analysis revealed that sleep duration did not mediate the relationship between comorbid factors (such as overall health, poverty index, obesity, and body mass index) and constipation,” they wrote.

The results suggest that decreased sleep is associated with constipation among adults in the United States, the researchers said. However, “further studies are needed to evaluate the physiologic mechanisms driving the impact of sleep duration on bowel function to determine whether sleep disorders or their underlying causes affect constipation,” they concluded.

“This study was necessary because up to 50% of Americans suffer from sleep disorders, out of which abnormal sleep duration is one of the most common and underdiagnosed, and associated with other diseases such as hypertension and diabetes,” Dr. Adejumo said in an interview. “However, disorders of bowel function (constipation and diarrhea), which affect almost 10%-15% of the population and result in significant health care burden, such as higher cost, hospital visits, abdominal discomfort, have not been studied among individuals with suboptimal sleep duration.”

Dr. Adejumo said he and his colleagues were surprised by their findings. “Although, based on our hypothesis, we thought that sleeping too long may be associated with constipation, we were shocked to note similar results among people who also sleep for short durations,” he noted.

“Previous studies had suggested that bowel contraction slows down considerably during sleep. It, therefore, will make sense that sleeping for too long may result in suppressed bowel motility and decreased bowel movement,” he said. “However, our results showed similar findings among short sleepers. We do not know the exact mechanism of these results. It may be that short sleep resulted in inadequate bowel rest, bowel muscle fatigue, and, subsequently, decreased bowel movement,” said Dr. Adejumo. “Or it may also be that brain-gut signaling pathways are disrupted among short sleepers, as is seen among IBS patients after a poor night sleep, resulting in higher constipation,” he added.

Clinicians should be aware of the impact of both short and long sleep on constipation, said Dr. Adejumo. “Individuals who are unable to have adequate periods of sleep due to other diseases, including insomnia, disrupted job schedules, or conditions with too long sleep, such as narcolepsy, may all additionally suffer from constipation. Such patients may need regular evaluation and treatment for constipation to improve their discomfort,” he said.

“To confirm our findings, other clinical studies with more granular data on sleep and constipation, are needed, as well as translational research to uncover the potential mechanisms of these findings,” he emphasized.

The researchers had no financial conflicts to disclose.
 

SOURCE: Adejumo A et al. DDW 2020. Abstract Sa1711.

Individuals who sleep more or less than average report significantly more constipation, compared with normal sleepers, based on data from 14,590 adults.

“Normal sleep duration is thought to be essential for healthy bowel function; however, the effect of either limited or excessive sleep duration on bowel patterns is poorly understood,” Adeyinka Adejumo, MD, of North Shore Medical Center, Salem, Mass., and colleagues wrote in an abstract released as part of the annual Digestive Disease Week^®, which was canceled because of COVID-19.

To examine the association between sleep duration and bowel function, the researchers identified 14,590 adults aged 20 years and older who completed questionnaires on sleep and bowel health as part of the National Health and Nutrition Examination Survey (NHANES) during 2005-2010.

Sleep was divided into three categories based on standards from the National Sleep Foundation: short (less than 7 hours), normal (7-8 hours) and long (more than 8 hours).

Overall, constipation rates were significantly lower among normal sleepers (8.3%) compared with both short and long sleepers (11.0% and 12.5%, respectively; P < .0001 for both).

Bowel function was defined as normal, constipation, or diarrhea based on stool form and bowel movements per week. After controlling for demographic, lifestyle, and dietary factors, long sleepers and short sleepers were 61% and 38% more likely, respectively, to report constipation, compared with normal sleepers.

However, sleep duration was not related to diarrhea, the researchers noted. In addition, “A sensitivity analysis revealed that sleep duration did not mediate the relationship between comorbid factors (such as overall health, poverty index, obesity, and body mass index) and constipation,” they wrote.

The results suggest that decreased sleep is associated with constipation among adults in the United States, the researchers said. However, “further studies are needed to evaluate the physiologic mechanisms driving the impact of sleep duration on bowel function to determine whether sleep disorders or their underlying causes affect constipation,” they concluded.

“This study was necessary because up to 50% of Americans suffer from sleep disorders, out of which abnormal sleep duration is one of the most common and underdiagnosed, and associated with other diseases such as hypertension and diabetes,” Dr. Adejumo said in an interview. “However, disorders of bowel function (constipation and diarrhea), which affect almost 10%-15% of the population and result in significant health care burden, such as higher cost, hospital visits, abdominal discomfort, have not been studied among individuals with suboptimal sleep duration.”

Dr. Adejumo said he and his colleagues were surprised by their findings. “Although, based on our hypothesis, we thought that sleeping too long may be associated with constipation, we were shocked to note similar results among people who also sleep for short durations,” he noted.

“Previous studies had suggested that bowel contraction slows down considerably during sleep. It, therefore, will make sense that sleeping for too long may result in suppressed bowel motility and decreased bowel movement,” he said. “However, our results showed similar findings among short sleepers. We do not know the exact mechanism of these results. It may be that short sleep resulted in inadequate bowel rest, bowel muscle fatigue, and, subsequently, decreased bowel movement,” said Dr. Adejumo. “Or it may also be that brain-gut signaling pathways are disrupted among short sleepers, as is seen among IBS patients after a poor night sleep, resulting in higher constipation,” he added.

Clinicians should be aware of the impact of both short and long sleep on constipation, said Dr. Adejumo. “Individuals who are unable to have adequate periods of sleep due to other diseases, including insomnia, disrupted job schedules, or conditions with too long sleep, such as narcolepsy, may all additionally suffer from constipation. Such patients may need regular evaluation and treatment for constipation to improve their discomfort,” he said.

“To confirm our findings, other clinical studies with more granular data on sleep and constipation, are needed, as well as translational research to uncover the potential mechanisms of these findings,” he emphasized.

The researchers had no financial conflicts to disclose.
 

SOURCE: Adejumo A et al. DDW 2020. Abstract Sa1711.

It’s anything but business as usual for clinicians who oversee office-based infusion centers, as they scramble to maintain services for patients considered to be at heightened risk for severe illness should they become infected with COVID-19.

Courtesy Dr. Alyssa M. Parian

“For many reasons, the guidance for patients right now is that they stay on their medications,” Max I. Hamburger, MD, a managing partner at Rheumatology Associates of Long Island (N.Y.), said in an interview. “Some have decided to stop the drug, and then they call us up to tell us that they’re flaring. The beginning of a flare is tiredness and other things. Now they’re worried: Are they tired because of the disease, or are they tired because they have COVID-19?”

With five offices located in a region considered to be the epicenter of the COVID-19 pandemic in the United States, Dr. Hamburger and his colleagues are hypervigilant about screening patients for symptoms of the virus before they visit one of the three practice locations that provide infusion services. This starts with an automated phone system that reminds patients of their appointment time. “Part of that robocall now has some questions like, ‘Do you have any symptoms of COVID-19?’ ‘Are you running a fever?’ ” The infusion nurses are also calling the patients in advance of their appointment to check on their status. “When they get to the office location, we ask them again about their general health and check their temperature,” said Dr. Hamburger. “We’re doing everything we can to talk to them about their own state of health and to question them about what I call extended paranoia: like, ‘Who are you living with?’ ‘Who are you hanging out with?’... We do everything we can to see if there’s anybody who might have had the slightest [contact with someone who has COVID-19]. Because if I lose my infusion nurse, then I’m up the creek.”

The infusion nurse wears scrubs, a face mask, and latex gloves. She and her staff are using hand sanitizer and cleaning infusion equipment with sanitizing wipes as one might do in a surgical setting. “Every surface is wiped down between patients, and the nurse is changing gloves between patients,” said Dr. Hamburger, who was founding president of the New York State Rheumatology Society before retiring from that post in 2017. “Getting masks has been tough. We’re doing the best we can there. We’re not gloving patients but we’re masking patients.”

As noted in guidance from the American College of Rheumatology and other medical organizations, following the Center for Disease Control and Prevention’s recommendation to stay at home during the pandemic has jump-started conversations between physicians and their patients about modifying the time interval between infusions. “If they have been doing well for the last 9 months, we’re having a conversation such as ‘Maybe instead of getting your Orencia every 4 weeks, maybe we’ll push it out to 5 weeks, or maybe we’ll push the Enbrel out to 10 days and the Humira out 3 weeks, et cetera,” Dr. Hamburger said. “One has to be very careful about when you do that, because you don’t want the patient to flare up because it’s hard to get them in, but it is a natural opportunity to look at this. We’re seeing how we can optimize the dose, but I don’t want to send the message that we’re doing this because it changes the patient’s outcome, because there’s zero evidence that it’s a good thing to do in terms of resistance.”

At the infusion centers operated by the Johns Hopkins division of gastroenterology and hepatology, Baltimore, clinicians are not increasing the time interval between infusions for patients at this time. “We’re keeping them as they are, to prevent any flare-ups. Our main goal is to keep patients in remission and out of the hospital,” said Alyssa M. Parian, MD, medical director of the infusion center and associate director of the university’s GI department. “With Remicade specifically, there’s also the risk of developing antibodies if you delay treatment, so we’re basically keeping everyone on track. We’re not recommending a switch from infusions to injectables, and we also are not speeding up infusions, either. Before this pandemic happened, we had already tried to decrease all Remicade infusions from 2 hours to 1 hour for patient satisfaction. The Entyvio is a pretty quick, 30-minute infusion.”

To accommodate patients during this era of physical distancing measures recommended by the CDC, Dr. Parian and her infusion nurse manager Elisheva Weiser converted one of their two outpatient GI centers into an infusion-only suite with 12 individual clinic rooms. As soon as patients exit the second-floor elevator, they encounter a workstation prior to entering the office where they are screened for COVID-19 symptoms and their temperature is taken. “If any symptoms or temperature comes back positive, we’re asking them to postpone their treatment and consider COVID testing,” she said.Instead of one nurse looking after four patients in one room during infusion therapy, now one nurse looks after two patients who are in rooms next to each other. All patients and all staff wear masks while in the center. “We always have physician oversight at our infusion centers,” Dr. Parian said. “We are trying to maintain a ‘COVID-free zone.’ Therefore, no physicians who have served in a hospital ward are allowed in the infusion suite because we don’t want any carriers of COVID-19. Same with the nurses. Additionally, we limit the staff within the suite to only those who are essential and don’t allow anyone to perform telemedicine or urgent clinic visits in this location. Our infusion center staff are on a strict protocol to not come in with any symptoms at all. They are asked to take their temperature before coming in to work.”

She and her colleagues drew from recommendations from the joint GI society message on COVID-19, the Crohn’s and Colitis Foundation, and the International Organization for the Study of Inflammatory Bowel Disease to inform their approach in serving patients during this unprecedented time. “We went as conservative as possible because these are immunosuppressed patients,” she said. One patient on her panel who receives an infusion every 8 weeks tested positive for COVID-19 between infusions, but was not hospitalized. Dr. Parian said that person will be treated only 14 days after all symptoms disappear. “That person will wear a mask and will be infused in a separate room,” she said.

AGA provides up-to-date news, resources and research COVID-19 to help the GI community navigate the coronavirus pandemic. Learn more at https://www.gastro.org/covid-19.

[email protected]

It’s anything but business as usual for clinicians who oversee office-based infusion centers, as they scramble to maintain services for patients considered to be at heightened risk for severe illness should they become infected with COVID-19.

Courtesy Dr. Alyssa M. Parian

“For many reasons, the guidance for patients right now is that they stay on their medications,” Max I. Hamburger, MD, a managing partner at Rheumatology Associates of Long Island (N.Y.), said in an interview. “Some have decided to stop the drug, and then they call us up to tell us that they’re flaring. The beginning of a flare is tiredness and other things. Now they’re worried: Are they tired because of the disease, or are they tired because they have COVID-19?”

With five offices located in a region considered to be the epicenter of the COVID-19 pandemic in the United States, Dr. Hamburger and his colleagues are hypervigilant about screening patients for symptoms of the virus before they visit one of the three practice locations that provide infusion services. This starts with an automated phone system that reminds patients of their appointment time. “Part of that robocall now has some questions like, ‘Do you have any symptoms of COVID-19?’ ‘Are you running a fever?’ ” The infusion nurses are also calling the patients in advance of their appointment to check on their status. “When they get to the office location, we ask them again about their general health and check their temperature,” said Dr. Hamburger. “We’re doing everything we can to talk to them about their own state of health and to question them about what I call extended paranoia: like, ‘Who are you living with?’ ‘Who are you hanging out with?’... We do everything we can to see if there’s anybody who might have had the slightest [contact with someone who has COVID-19]. Because if I lose my infusion nurse, then I’m up the creek.”

The infusion nurse wears scrubs, a face mask, and latex gloves. She and her staff are using hand sanitizer and cleaning infusion equipment with sanitizing wipes as one might do in a surgical setting. “Every surface is wiped down between patients, and the nurse is changing gloves between patients,” said Dr. Hamburger, who was founding president of the New York State Rheumatology Society before retiring from that post in 2017. “Getting masks has been tough. We’re doing the best we can there. We’re not gloving patients but we’re masking patients.”

As noted in guidance from the American College of Rheumatology and other medical organizations, following the Center for Disease Control and Prevention’s recommendation to stay at home during the pandemic has jump-started conversations between physicians and their patients about modifying the time interval between infusions. “If they have been doing well for the last 9 months, we’re having a conversation such as ‘Maybe instead of getting your Orencia every 4 weeks, maybe we’ll push it out to 5 weeks, or maybe we’ll push the Enbrel out to 10 days and the Humira out 3 weeks, et cetera,” Dr. Hamburger said. “One has to be very careful about when you do that, because you don’t want the patient to flare up because it’s hard to get them in, but it is a natural opportunity to look at this. We’re seeing how we can optimize the dose, but I don’t want to send the message that we’re doing this because it changes the patient’s outcome, because there’s zero evidence that it’s a good thing to do in terms of resistance.”

At the infusion centers operated by the Johns Hopkins division of gastroenterology and hepatology, Baltimore, clinicians are not increasing the time interval between infusions for patients at this time. “We’re keeping them as they are, to prevent any flare-ups. Our main goal is to keep patients in remission and out of the hospital,” said Alyssa M. Parian, MD, medical director of the infusion center and associate director of the university’s GI department. “With Remicade specifically, there’s also the risk of developing antibodies if you delay treatment, so we’re basically keeping everyone on track. We’re not recommending a switch from infusions to injectables, and we also are not speeding up infusions, either. Before this pandemic happened, we had already tried to decrease all Remicade infusions from 2 hours to 1 hour for patient satisfaction. The Entyvio is a pretty quick, 30-minute infusion.”

To accommodate patients during this era of physical distancing measures recommended by the CDC, Dr. Parian and her infusion nurse manager Elisheva Weiser converted one of their two outpatient GI centers into an infusion-only suite with 12 individual clinic rooms. As soon as patients exit the second-floor elevator, they encounter a workstation prior to entering the office where they are screened for COVID-19 symptoms and their temperature is taken. “If any symptoms or temperature comes back positive, we’re asking them to postpone their treatment and consider COVID testing,” she said.Instead of one nurse looking after four patients in one room during infusion therapy, now one nurse looks after two patients who are in rooms next to each other. All patients and all staff wear masks while in the center. “We always have physician oversight at our infusion centers,” Dr. Parian said. “We are trying to maintain a ‘COVID-free zone.’ Therefore, no physicians who have served in a hospital ward are allowed in the infusion suite because we don’t want any carriers of COVID-19. Same with the nurses. Additionally, we limit the staff within the suite to only those who are essential and don’t allow anyone to perform telemedicine or urgent clinic visits in this location. Our infusion center staff are on a strict protocol to not come in with any symptoms at all. They are asked to take their temperature before coming in to work.”

She and her colleagues drew from recommendations from the joint GI society message on COVID-19, the Crohn’s and Colitis Foundation, and the International Organization for the Study of Inflammatory Bowel Disease to inform their approach in serving patients during this unprecedented time. “We went as conservative as possible because these are immunosuppressed patients,” she said. One patient on her panel who receives an infusion every 8 weeks tested positive for COVID-19 between infusions, but was not hospitalized. Dr. Parian said that person will be treated only 14 days after all symptoms disappear. “That person will wear a mask and will be infused in a separate room,” she said.

AGA provides up-to-date news, resources and research COVID-19 to help the GI community navigate the coronavirus pandemic. Learn more at https://www.gastro.org/covid-19.

[email protected]

It’s anything but business as usual for clinicians who oversee office-based infusion centers, as they scramble to maintain services for patients considered to be at heightened risk for severe illness should they become infected with COVID-19.

Courtesy Dr. Alyssa M. Parian

“For many reasons, the guidance for patients right now is that they stay on their medications,” Max I. Hamburger, MD, a managing partner at Rheumatology Associates of Long Island (N.Y.), said in an interview. “Some have decided to stop the drug, and then they call us up to tell us that they’re flaring. The beginning of a flare is tiredness and other things. Now they’re worried: Are they tired because of the disease, or are they tired because they have COVID-19?”

With five offices located in a region considered to be the epicenter of the COVID-19 pandemic in the United States, Dr. Hamburger and his colleagues are hypervigilant about screening patients for symptoms of the virus before they visit one of the three practice locations that provide infusion services. This starts with an automated phone system that reminds patients of their appointment time. “Part of that robocall now has some questions like, ‘Do you have any symptoms of COVID-19?’ ‘Are you running a fever?’ ” The infusion nurses are also calling the patients in advance of their appointment to check on their status. “When they get to the office location, we ask them again about their general health and check their temperature,” said Dr. Hamburger. “We’re doing everything we can to talk to them about their own state of health and to question them about what I call extended paranoia: like, ‘Who are you living with?’ ‘Who are you hanging out with?’... We do everything we can to see if there’s anybody who might have had the slightest [contact with someone who has COVID-19]. Because if I lose my infusion nurse, then I’m up the creek.”

The infusion nurse wears scrubs, a face mask, and latex gloves. She and her staff are using hand sanitizer and cleaning infusion equipment with sanitizing wipes as one might do in a surgical setting. “Every surface is wiped down between patients, and the nurse is changing gloves between patients,” said Dr. Hamburger, who was founding president of the New York State Rheumatology Society before retiring from that post in 2017. “Getting masks has been tough. We’re doing the best we can there. We’re not gloving patients but we’re masking patients.”

As noted in guidance from the American College of Rheumatology and other medical organizations, following the Center for Disease Control and Prevention’s recommendation to stay at home during the pandemic has jump-started conversations between physicians and their patients about modifying the time interval between infusions. “If they have been doing well for the last 9 months, we’re having a conversation such as ‘Maybe instead of getting your Orencia every 4 weeks, maybe we’ll push it out to 5 weeks, or maybe we’ll push the Enbrel out to 10 days and the Humira out 3 weeks, et cetera,” Dr. Hamburger said. “One has to be very careful about when you do that, because you don’t want the patient to flare up because it’s hard to get them in, but it is a natural opportunity to look at this. We’re seeing how we can optimize the dose, but I don’t want to send the message that we’re doing this because it changes the patient’s outcome, because there’s zero evidence that it’s a good thing to do in terms of resistance.”

At the infusion centers operated by the Johns Hopkins division of gastroenterology and hepatology, Baltimore, clinicians are not increasing the time interval between infusions for patients at this time. “We’re keeping them as they are, to prevent any flare-ups. Our main goal is to keep patients in remission and out of the hospital,” said Alyssa M. Parian, MD, medical director of the infusion center and associate director of the university’s GI department. “With Remicade specifically, there’s also the risk of developing antibodies if you delay treatment, so we’re basically keeping everyone on track. We’re not recommending a switch from infusions to injectables, and we also are not speeding up infusions, either. Before this pandemic happened, we had already tried to decrease all Remicade infusions from 2 hours to 1 hour for patient satisfaction. The Entyvio is a pretty quick, 30-minute infusion.”

To accommodate patients during this era of physical distancing measures recommended by the CDC, Dr. Parian and her infusion nurse manager Elisheva Weiser converted one of their two outpatient GI centers into an infusion-only suite with 12 individual clinic rooms. As soon as patients exit the second-floor elevator, they encounter a workstation prior to entering the office where they are screened for COVID-19 symptoms and their temperature is taken. “If any symptoms or temperature comes back positive, we’re asking them to postpone their treatment and consider COVID testing,” she said.Instead of one nurse looking after four patients in one room during infusion therapy, now one nurse looks after two patients who are in rooms next to each other. All patients and all staff wear masks while in the center. “We always have physician oversight at our infusion centers,” Dr. Parian said. “We are trying to maintain a ‘COVID-free zone.’ Therefore, no physicians who have served in a hospital ward are allowed in the infusion suite because we don’t want any carriers of COVID-19. Same with the nurses. Additionally, we limit the staff within the suite to only those who are essential and don’t allow anyone to perform telemedicine or urgent clinic visits in this location. Our infusion center staff are on a strict protocol to not come in with any symptoms at all. They are asked to take their temperature before coming in to work.”

She and her colleagues drew from recommendations from the joint GI society message on COVID-19, the Crohn’s and Colitis Foundation, and the International Organization for the Study of Inflammatory Bowel Disease to inform their approach in serving patients during this unprecedented time. “We went as conservative as possible because these are immunosuppressed patients,” she said. One patient on her panel who receives an infusion every 8 weeks tested positive for COVID-19 between infusions, but was not hospitalized. Dr. Parian said that person will be treated only 14 days after all symptoms disappear. “That person will wear a mask and will be infused in a separate room,” she said.

AGA provides up-to-date news, resources and research COVID-19 to help the GI community navigate the coronavirus pandemic. Learn more at https://www.gastro.org/covid-19.

[email protected]

For seriously ill patients with multidrug-resistant organisms (MDROs) in their gastrointestinal tract, performing a fecal microbiota transplant (FMT) may result in fewer and less severe infections, as well as shorter hospital stays, according to investigators.

Significant clinical improvements were observed across the group even though 59% of patients did not clear MDROs, which suggests that complete decolonization of resistant organisms may be unnecessary for patients to benefit from FMT, reported lead author Julian Marchesi, PhD, of Cardiff (Wales) University and Imperial College London (England).

“We see the quality of life for these patients is hugely improved even when we don’t get rid of the organism totally,” Dr. Marchesi said in a virtual press conference.

Although previous studies have suggested that FMT may be used to decolonize MDROs, little research has addressed other clinical outcomes, the investigators wrote in an abstract released as part of the annual Digestive Disease Week®, which was canceled because of COVID-19.

The present study involved 20 patients with MDROs, including extended-spectrum beta-lactamase Enterobacteriaceae (ESBL), carbapenemase-producing Enterobacteriaceae (CPE), or vancomycin-resistant enterococci (VRE). Approximately half of the population (n = 11) had chronic hematological disease. The other half (n = 9) had recurrent urinary tract infections with ESBL, including patients who had undergone renal transplant or had recurrent Clostridioides difficile infection.

For each transplant, 200-300 mL of fecal slurry was delivered via nasogastric tube into the small intestine. Fecal donors underwent a strict screening process that included blood, fecal, and behavioral testing.

Multiple clinical outcomes were evaluated in the 6 months leading up to FMT, then compared with outcomes in the 6 months following fecal transplant. Out of 20 patients, 17 completed the 6-month follow-up. Although only 7 of these patients (41%) were decolonized of MDROs, multiple significant clinical improvements were observed across the group, including reductions in MDRO bloodstream infections (P = .047), all bloodstream infections (P = .03), length of stay in hospital (P = .0002), and duration of carbapenem use (P = .0005). Eight out of 11 patients with hematologic disease improved enough to undergo stem cell transplantation within 6 months of FMT, and in the subgroup of patients who had undergone renal transplant, the rate of urinary tract infections was significantly improved (P = .008).

No serious adverse events were encountered during the trial, which led the investigators to conclude that FMT was safe and well tolerated, even in patients with bloodstream infections and those who were highly immunosuppressed.

Beyond clinical implications, Dr. Marchesi suggested that the study findings should influence FMT trial methodology.

“We’ve got to start thinking a little bit differently in terms of how we measure the impact of FMT,” he said. “It’s not all about ... getting rid of these opportunistic pathogens. There are other quality-of-life factors that we need to measure, because they’re also important for the patient.”

Dr. Marchesi said that more research is needed to confirm findings and gain a mechanistic understanding of why patients may improve despite a lack of decolonization.

“We think we’re on a strong foundation here to take this into a clinical trial,” he said.

The research was funded by the National Institute for Health Research and the Medical Research Council. The investigators reported no conflicts of interest.

For seriously ill patients with multidrug-resistant organisms (MDROs) in their gastrointestinal tract, performing a fecal microbiota transplant (FMT) may result in fewer and less severe infections, as well as shorter hospital stays, according to investigators.

Significant clinical improvements were observed across the group even though 59% of patients did not clear MDROs, which suggests that complete decolonization of resistant organisms may be unnecessary for patients to benefit from FMT, reported lead author Julian Marchesi, PhD, of Cardiff (Wales) University and Imperial College London (England).

“We see the quality of life for these patients is hugely improved even when we don’t get rid of the organism totally,” Dr. Marchesi said in a virtual press conference.

Although previous studies have suggested that FMT may be used to decolonize MDROs, little research has addressed other clinical outcomes, the investigators wrote in an abstract released as part of the annual Digestive Disease Week®, which was canceled because of COVID-19.

The present study involved 20 patients with MDROs, including extended-spectrum beta-lactamase Enterobacteriaceae (ESBL), carbapenemase-producing Enterobacteriaceae (CPE), or vancomycin-resistant enterococci (VRE). Approximately half of the population (n = 11) had chronic hematological disease. The other half (n = 9) had recurrent urinary tract infections with ESBL, including patients who had undergone renal transplant or had recurrent Clostridioides difficile infection.

For each transplant, 200-300 mL of fecal slurry was delivered via nasogastric tube into the small intestine. Fecal donors underwent a strict screening process that included blood, fecal, and behavioral testing.

Multiple clinical outcomes were evaluated in the 6 months leading up to FMT, then compared with outcomes in the 6 months following fecal transplant. Out of 20 patients, 17 completed the 6-month follow-up. Although only 7 of these patients (41%) were decolonized of MDROs, multiple significant clinical improvements were observed across the group, including reductions in MDRO bloodstream infections (P = .047), all bloodstream infections (P = .03), length of stay in hospital (P = .0002), and duration of carbapenem use (P = .0005). Eight out of 11 patients with hematologic disease improved enough to undergo stem cell transplantation within 6 months of FMT, and in the subgroup of patients who had undergone renal transplant, the rate of urinary tract infections was significantly improved (P = .008).

No serious adverse events were encountered during the trial, which led the investigators to conclude that FMT was safe and well tolerated, even in patients with bloodstream infections and those who were highly immunosuppressed.

Beyond clinical implications, Dr. Marchesi suggested that the study findings should influence FMT trial methodology.

“We’ve got to start thinking a little bit differently in terms of how we measure the impact of FMT,” he said. “It’s not all about ... getting rid of these opportunistic pathogens. There are other quality-of-life factors that we need to measure, because they’re also important for the patient.”

Dr. Marchesi said that more research is needed to confirm findings and gain a mechanistic understanding of why patients may improve despite a lack of decolonization.

“We think we’re on a strong foundation here to take this into a clinical trial,” he said.

The research was funded by the National Institute for Health Research and the Medical Research Council. The investigators reported no conflicts of interest.

For seriously ill patients with multidrug-resistant organisms (MDROs) in their gastrointestinal tract, performing a fecal microbiota transplant (FMT) may result in fewer and less severe infections, as well as shorter hospital stays, according to investigators.

Significant clinical improvements were observed across the group even though 59% of patients did not clear MDROs, which suggests that complete decolonization of resistant organisms may be unnecessary for patients to benefit from FMT, reported lead author Julian Marchesi, PhD, of Cardiff (Wales) University and Imperial College London (England).

“We see the quality of life for these patients is hugely improved even when we don’t get rid of the organism totally,” Dr. Marchesi said in a virtual press conference.

Although previous studies have suggested that FMT may be used to decolonize MDROs, little research has addressed other clinical outcomes, the investigators wrote in an abstract released as part of the annual Digestive Disease Week®, which was canceled because of COVID-19.

The present study involved 20 patients with MDROs, including extended-spectrum beta-lactamase Enterobacteriaceae (ESBL), carbapenemase-producing Enterobacteriaceae (CPE), or vancomycin-resistant enterococci (VRE). Approximately half of the population (n = 11) had chronic hematological disease. The other half (n = 9) had recurrent urinary tract infections with ESBL, including patients who had undergone renal transplant or had recurrent Clostridioides difficile infection.

For each transplant, 200-300 mL of fecal slurry was delivered via nasogastric tube into the small intestine. Fecal donors underwent a strict screening process that included blood, fecal, and behavioral testing.

Multiple clinical outcomes were evaluated in the 6 months leading up to FMT, then compared with outcomes in the 6 months following fecal transplant. Out of 20 patients, 17 completed the 6-month follow-up. Although only 7 of these patients (41%) were decolonized of MDROs, multiple significant clinical improvements were observed across the group, including reductions in MDRO bloodstream infections (P = .047), all bloodstream infections (P = .03), length of stay in hospital (P = .0002), and duration of carbapenem use (P = .0005). Eight out of 11 patients with hematologic disease improved enough to undergo stem cell transplantation within 6 months of FMT, and in the subgroup of patients who had undergone renal transplant, the rate of urinary tract infections was significantly improved (P = .008).

No serious adverse events were encountered during the trial, which led the investigators to conclude that FMT was safe and well tolerated, even in patients with bloodstream infections and those who were highly immunosuppressed.

Beyond clinical implications, Dr. Marchesi suggested that the study findings should influence FMT trial methodology.

“We’ve got to start thinking a little bit differently in terms of how we measure the impact of FMT,” he said. “It’s not all about ... getting rid of these opportunistic pathogens. There are other quality-of-life factors that we need to measure, because they’re also important for the patient.”

Dr. Marchesi said that more research is needed to confirm findings and gain a mechanistic understanding of why patients may improve despite a lack of decolonization.

“We think we’re on a strong foundation here to take this into a clinical trial,” he said.

The research was funded by the National Institute for Health Research and the Medical Research Council. The investigators reported no conflicts of interest.