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Probiotics do not prevent gastroenteritis symptoms in children, studies show
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Probiotics did not provide beneficial effects in children with gastroenteritis in EDs in the United States and Canada, according to a pair of studies recently published in The New England Journal of Medicine.
The researchers wrote that gastroenteritis accounts for approximately 1.7 million visits by children to the ED in the U.S. each year but that data to support the use of probiotics are lacking.
In the first study, researchers conducted a randomized trial of 886 children aged 3 to 48 months with gastroenteritis who presented to six pediatric EDs in Canada. The study participants received a 5-day course of a combination probiotic product containing Lactobacillus rhamnosus R0011 and Lactobacillus helveticus R0052 twice daily or placebo.
The researchers reported that within 14 days of enrollment, 26.1% of the probiotic-assigned cohort and 24.7% of the placebo-assigned cohort experienced moderate-to-severe gastroenteritis (OR = 1.06: 95% CI, 0.77-1.46). After they adjusted for trial site, age, detection of rotavirus in stool and frequency of diarrhea and vomiting before enrollment, the researchers reported that assignment to a certain trial group did not predict moderate-to-severe gastroenteritis (OR = 1.06; 95% CI, 0.76-1.49).
“We analyzed numerous secondary outcomes including the duration of diarrhea and vomiting, and the percentage of children who had unscheduled physician visits, and we failed to identify any benefits among those who received probiotics as it relates to these outcomes as well,” Stephen B. Freedman, MDCM, MSc, an associate professor of pediatrics at Alberta Children’s Hospital and Research Institute, University of Calgary, told Infectious Diseases in Children. “We found no benefits associated with the administration of a Lactobacillus rhamnosus R0011 and L. helveticus R0052 combination probiotic product in children with infectious diarrhea.”
In the second study, Freedman and colleagues studied 971 children aged 3 to 48 months who presented to 10 pediatric EDs with acute gastroenteritis. The children received a 5-day course of L. rhamnosus GG twice daily or placebo. The researchers conducted follow-up surveys daily for 5 days and at 14 days and 1 month after enrollment.
Nine hundred forty-three patients (97.1%) completed the study, with a median age of 1.4 years. The researchers reported there were no significant differences between the two treatment cohorts in duration of diarrhea (median, 49.7 hours in the L rhamnosus GG cohort and 50.9 hours in the placebo cohort), duration of vomiting (median, 0 hours in both groups), day care absenteeism (median, 2 days in both groups) or rate of household transmission (10.6% in the L rhamnosus GG cohort and 14.1% in the placebo cohort).
“We found that probiotic administration did not prevent the development of moderate-to-severe gastroenteritis within 14 days after enrollment,” Freedman, who was a researcher on both studies, said. “We analyzed numerous secondary outcomes including the duration and frequency of diarrhea and vomiting, the duration of day care absenteeism, and the household transmission rate, and we failed to identify any benefits among those who received probiotics as it relates to these outcomes as well. We found no benefits associated with the administration of L. rhamnosus GG in children with infectious diarrhea.” – by Bruce Thiel
Disclosures: Infectious Diseases in Children was unable to confirm relevant financial disclosures prior to publication.
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