Lack of Efficacy of Lactobacillus reuteri DSM 17938 for the Treatment of Acute Gastroenteritis: A Randomized Controlled Trial.

Abstract

To assess the efficacy of Lactobacillus reuteri DSM 17938 (L. reuteri) for the treatment of acute gastroenteritis in children. 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. 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. 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.