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.