Lack of an effect of Lactobacillus reuteri DSM 17938 in preventing nosocomial diarrhea in children: a randomized, double-blind, placebo-controlled trial

Abstract

Objective: To evaluate the efficacy of administering Lactobacillus reuteri DSM 17938 for the prevention of nosocomial diarrhea.

Study design: Children (n = 106; aged 1-48 months) admitted to the hospital for reasons other than diarrhea were enrolled in a randomized, double-blind, placebo-controlled trial. They received L reuteri DSM 17938 at a dose of 10(8) colony-forming units (n = 54) or a placebo (n = 52) orally, once daily, for the duration of the hospital stay.

Results: Data from all children were included in the final analysis. L reuteri DSM 17938 did not significantly affect the risk of developing nosocomial diarrhea, defined as 3 loose or watery stools per day in a 24-hour period that occurred >72 hours after admission (risk ratio 1.06, 95% CI 0.7-1.5) or rotavirus infection (1.04, 0.6-1.6). There was also no difference between the probiotic and placebo groups for any of the other secondary outcomes (ie, incidence of rotavirus infection, incidence of diarrhea, duration of diarrhea, incidence of recurrent diarrhea, incidence of chronic diarrhea, length of hospital stay in days, and frequency of need for rehydration). No adverse events were reported.

Conclusion: In hospitalized children, the administration of L reuteri DSM 17938 compared with placebo had no effect on the overall incidence of nosocomial diarrhea, including rotavirus infection.

Trial registration: ClinicalTrials.gov NCT01046656.