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Giving the probiotic supplement Lactobacillus rhamnosus GG (LGG) to high-risk infants in the first 6 months of life is not effective in lessening incidence of eczema, asthma, or rhinitis in later childhood, researchers have found.
The researchers, led by Michael D. Cabana, MD, MPH, with the Children’s Hospital of Montefiore, New York, said they cannot support its use in this population of children at high risk for allergic disease. Findings were published in Pediatrics.
Jonathan Spergel, MD, PhD, chief of the allergy program at Children’s Hospital of Philadelphia, who was not part of the study, said the “small, but very interesting study adds to the literature indicating that allergy prevention needs to be a multifactorial approach and simply adding LGG in a select population makes no difference.”
He noted that the study of probiotics for allergic conditions is complex as it depends on many factors, such as the child’s environment, including exposure to pets and pollution, and whether the child was delivered vaginally or by cesarean section.
Study builds on previous work
The new study builds on the same researchers’ randomized, double-masked, parallel-arm, controlled Trial of Infant Probiotic Supplementation (TIPS). That study investigated whether daily administration of LGG in the first 6 months to children at high risk for allergic disease because of asthma in a parent, could decrease their cumulative incidence of eczema. Investigators found LGG had no effect.
These additional results included participants at least 7 years old and also included physician-diagnosed asthma and physician-diagnosed rhinitis as secondary outcomes.
Retention rate over the 7-year follow-up was 56%; 49 (53%) of 92 in the intervention group and 54 (59%) of 92 in the control group.
The researchers performed modified intention-to-treat analyses with all children who received treatment in the study arm to which they had been randomized.
Eczema was diagnosed in 78 participants, asthma in 32, and rhinitis in 15. Incidence of eczema was high in infancy, but low thereafter. Incidence rates for asthma and rhinitis were constant throughout childhood.
The researchers used modeling to compare the incidence of each outcome between the intervention and control groups, adjusting for mode of delivery and how long a child was breastfed.
Cesarean delivery was linked to a greater incidence of rhinitis, with a hazard ratio of 3.33 (95% confidence interval, 1.21-9.21).
Finding the right strain
Heather Cassell, MD, a pediatric allergist and immunologist at University of Arizona, Tucson, who was not part of the study, said in an interview that many researchers, including those at her institution, are trying to find which strain of probiotic might be beneficial in lowering risk for allergic disease.
Though it appears LGG doesn’t have an effect, she said, another strain might be successful and this helps zero in on the right one.
The TIPS trial showed that there were no significant side effects from giving LGG early, which is good information to have as the search resumes for the right strain, she said.
“We know that there’s probably some immune dysregulation in kids with asthma, eczema, other allergies, but we don’t fully know the extent of it,” she said, adding that it may be that skin flora or respiratory flora and microbiomes in other parts of the body play a role.
“We don’t have bacteria just in our guts,” she noted. “It may be a combination of strains or a combination of bacteria.”
The authors, Dr. Spergel, and Dr. Cassell reported no relevant financial relationships.
Giving the probiotic supplement Lactobacillus rhamnosus GG (LGG) to high-risk infants in the first 6 months of life is not effective in lessening incidence of eczema, asthma, or rhinitis in later childhood, researchers have found.
The researchers, led by Michael D. Cabana, MD, MPH, with the Children’s Hospital of Montefiore, New York, said they cannot support its use in this population of children at high risk for allergic disease. Findings were published in Pediatrics.
Jonathan Spergel, MD, PhD, chief of the allergy program at Children’s Hospital of Philadelphia, who was not part of the study, said the “small, but very interesting study adds to the literature indicating that allergy prevention needs to be a multifactorial approach and simply adding LGG in a select population makes no difference.”
He noted that the study of probiotics for allergic conditions is complex as it depends on many factors, such as the child’s environment, including exposure to pets and pollution, and whether the child was delivered vaginally or by cesarean section.
Study builds on previous work
The new study builds on the same researchers’ randomized, double-masked, parallel-arm, controlled Trial of Infant Probiotic Supplementation (TIPS). That study investigated whether daily administration of LGG in the first 6 months to children at high risk for allergic disease because of asthma in a parent, could decrease their cumulative incidence of eczema. Investigators found LGG had no effect.
These additional results included participants at least 7 years old and also included physician-diagnosed asthma and physician-diagnosed rhinitis as secondary outcomes.
Retention rate over the 7-year follow-up was 56%; 49 (53%) of 92 in the intervention group and 54 (59%) of 92 in the control group.
The researchers performed modified intention-to-treat analyses with all children who received treatment in the study arm to which they had been randomized.
Eczema was diagnosed in 78 participants, asthma in 32, and rhinitis in 15. Incidence of eczema was high in infancy, but low thereafter. Incidence rates for asthma and rhinitis were constant throughout childhood.
The researchers used modeling to compare the incidence of each outcome between the intervention and control groups, adjusting for mode of delivery and how long a child was breastfed.
Cesarean delivery was linked to a greater incidence of rhinitis, with a hazard ratio of 3.33 (95% confidence interval, 1.21-9.21).
Finding the right strain
Heather Cassell, MD, a pediatric allergist and immunologist at University of Arizona, Tucson, who was not part of the study, said in an interview that many researchers, including those at her institution, are trying to find which strain of probiotic might be beneficial in lowering risk for allergic disease.
Though it appears LGG doesn’t have an effect, she said, another strain might be successful and this helps zero in on the right one.
The TIPS trial showed that there were no significant side effects from giving LGG early, which is good information to have as the search resumes for the right strain, she said.
“We know that there’s probably some immune dysregulation in kids with asthma, eczema, other allergies, but we don’t fully know the extent of it,” she said, adding that it may be that skin flora or respiratory flora and microbiomes in other parts of the body play a role.
“We don’t have bacteria just in our guts,” she noted. “It may be a combination of strains or a combination of bacteria.”
The authors, Dr. Spergel, and Dr. Cassell reported no relevant financial relationships.
Giving the probiotic supplement Lactobacillus rhamnosus GG (LGG) to high-risk infants in the first 6 months of life is not effective in lessening incidence of eczema, asthma, or rhinitis in later childhood, researchers have found.
The researchers, led by Michael D. Cabana, MD, MPH, with the Children’s Hospital of Montefiore, New York, said they cannot support its use in this population of children at high risk for allergic disease. Findings were published in Pediatrics.
Jonathan Spergel, MD, PhD, chief of the allergy program at Children’s Hospital of Philadelphia, who was not part of the study, said the “small, but very interesting study adds to the literature indicating that allergy prevention needs to be a multifactorial approach and simply adding LGG in a select population makes no difference.”
He noted that the study of probiotics for allergic conditions is complex as it depends on many factors, such as the child’s environment, including exposure to pets and pollution, and whether the child was delivered vaginally or by cesarean section.
Study builds on previous work
The new study builds on the same researchers’ randomized, double-masked, parallel-arm, controlled Trial of Infant Probiotic Supplementation (TIPS). That study investigated whether daily administration of LGG in the first 6 months to children at high risk for allergic disease because of asthma in a parent, could decrease their cumulative incidence of eczema. Investigators found LGG had no effect.
These additional results included participants at least 7 years old and also included physician-diagnosed asthma and physician-diagnosed rhinitis as secondary outcomes.
Retention rate over the 7-year follow-up was 56%; 49 (53%) of 92 in the intervention group and 54 (59%) of 92 in the control group.
The researchers performed modified intention-to-treat analyses with all children who received treatment in the study arm to which they had been randomized.
Eczema was diagnosed in 78 participants, asthma in 32, and rhinitis in 15. Incidence of eczema was high in infancy, but low thereafter. Incidence rates for asthma and rhinitis were constant throughout childhood.
The researchers used modeling to compare the incidence of each outcome between the intervention and control groups, adjusting for mode of delivery and how long a child was breastfed.
Cesarean delivery was linked to a greater incidence of rhinitis, with a hazard ratio of 3.33 (95% confidence interval, 1.21-9.21).
Finding the right strain
Heather Cassell, MD, a pediatric allergist and immunologist at University of Arizona, Tucson, who was not part of the study, said in an interview that many researchers, including those at her institution, are trying to find which strain of probiotic might be beneficial in lowering risk for allergic disease.
Though it appears LGG doesn’t have an effect, she said, another strain might be successful and this helps zero in on the right one.
The TIPS trial showed that there were no significant side effects from giving LGG early, which is good information to have as the search resumes for the right strain, she said.
“We know that there’s probably some immune dysregulation in kids with asthma, eczema, other allergies, but we don’t fully know the extent of it,” she said, adding that it may be that skin flora or respiratory flora and microbiomes in other parts of the body play a role.
“We don’t have bacteria just in our guts,” she noted. “It may be a combination of strains or a combination of bacteria.”
The authors, Dr. Spergel, and Dr. Cassell reported no relevant financial relationships.
FROM PEDIATRICS