MONDAY, Nov. 26, 2018 (HealthDay News) -- For children with acute gastroenteritis, probiotics show no significant benefit versus placebo, according to two studies published in the Nov. 22 issue of the New England Journal of Medicine.
David Schnadower, M.D., M.P.H., from the Washington University School of Medicine in St. Louis, and colleagues conducted a randomized double-blind trial involving 971 children aged 3 months to 4 years with acute gastroenteritis. Participants received a five-day course of Lactobacillus rhamnosus GG or matching placebo. Overall, 943 participants completed the trial. The researchers found that for the 14-day period after enrollment, the modified Vesikari scale score was 9 or higher in 11.8 and 12.6 percent of participants in the L. rhamnosus GG group and the placebo group, respectively (relative risk, 0.96; 95 percent confidence interval, 0.68 to 1.35; P = 0.83).
Stephen B. Freedman, M.D.C.M., from Alberta Children's Hospital in Calgary, Canada, and colleagues conducted a randomized double-blind trial involving 886 children aged 3 to 48 months of age with gastroenteritis. Participants were randomly assigned to receive a five-day course of a combination probiotic product containing L. rhamnosus R0011 and L. helveticus R0052 or placebo. The researchers found that 26.1 and 24.7 percent of participants assigned to probiotics and placebo, respectively, had moderate-to-severe gastroenteritis within 14 days after enrollment (odds ratio, 1.06; 95 percent confidence interval, 0.77 to 1.46; P = 0.72).
"These negative trial data will be valuable to clinicians and professional bodies in making decisions regarding the use of either of these probiotic formulations in children with diarrhea," write the authors of an accompanying editorial.
The Freedman study was partially funded by Luminex and Copan Italia; one author disclosed ties to the pharmaceutical and nutrition industries. The Schnadower study was partly supported by iHealth.