Lack of Efficacy of Lactobacillus reuteri DSM 17938 for the Treatment of Acute Gastroenteritis: A Randomized Controlled Trial
Abstract
OBJECTIVE
To assess the efficacy of Lactobacillus reuteri DSM 17938 (L. reuteri) for the treatment of acute gastroenteritis in children.
STUDY DESIGN
Children younger than 5 years with acute diarrhea, defined as a change in stool consistency to a loose or liquid form and/or an increase in the frequency of evacuations (≥3 in 24 hours), lasting for no longer than 5 days, were eligible for inclusion. Participants (n = 100) were recruited from the pediatrics department of a Polish hospital and randomly assigned to receive L. reuteri in a dose 2 × 10 colony-forming units or placebo, for 5 days, in addition to standard rehydration therapy. The primary outcome measure was duration of diarrhea.
RESULTS
Ninety-one of the 100 children randomized were included in the intention-to-treat analysis (L. reuteri n = 44; placebo n = 47). The duration of diarrhea after randomization in both groups was similar (P = 0.6). The groups were also similar with respect to all secondary outcome measures, with one exception. Compared with the placebo group, patients in the L. reuteri group had a shorter duration of hospitalization (P = 0.048). Adverse events were similar in both groups.
CONCLUSIONS
Among children with acute gastroenteritis who were younger than 5 years of age, L. reuteri compared with placebo, as an adjunct to rehydration therapy, did not reduce the duration of diarrhea; however, it reduced the duration of hospitalization.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 100 participants or records.
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