Effectiveness of Lactobacillus reuteri DSM 17938 for the Prevention of Nosocomial Diarrhea in Children: A Randomized, Double-blind, Placebo-controlled Trial.

Background: Multiple studies of probiotics used to prevent nosocomial diarrhea have provided conflicting results. The effects likely depend on the probiotic strain and/or dosage. The aim of this study was to assess the effectiveness of Lactobacillus reuteri DSM 17938 (L. reuteri; daily dose of 1 × 109 colony forming units) for preventing nosocomial diarrhea in children. Methods: We conducted a multicenter, randomized, double-blind, placebo-controlled trial in 184 children, 1–48 months of age, admitted to the hospital for reasons other than diarrhea. A computer-generated randomization scheme was used to allocate participants to receive either L. reuteri (n = 91) at a daily dose of 1 × 109 colony forming units, for the duration of hospitalization, or an identical appearing placebo (n = 93). Patients, study personnel and data analysts were blinded to assignment. The primary outcome was the occurrence of nosocomial diarrhea (≥3 loose or watery stools in 24 hours that occurred >72 hours after admission). Analysis was by intention-to-treat. Results: Baseline characteristics were similar in the 2 groups. Nosocomial diarrhea occurred in 13 (7.1%) children. No difference was found between the L. reuteri and the placebo groups (7/91 vs 6/93, respectively; relative risk: 1.19; 95% confidence interval: 0.43–3.27). There was also no difference between the L. reuteri and placebo groups for any of the secondary outcomes, including adverse effects. Rotavirus vaccination status had no effect on the results. Conclusion: L. reuteri in the dosage regimen used was not effective in preventing nosocomial diarrhea in children.