Original ArticleLack of an Effect of Lactobacillus reuteri DSM 17938 in Preventing Nosocomial Diarrhea in Children: A Randomized, Double-Blind, Placebo-Controlled Trial
Section snippets
Methods
The standards from the guidelines of the Consolidated Standards of Reporting Trials were followed for this randomized controlled trial (RCT). This trial was registered at ClinicalTrials.gov (NCT01046656). The study was approved by the Ethics Committee of the Medical University of Warsaw. Parents were fully informed about the aims of the study, and informed consent was obtained from at least 1 parent.
This was a prospective, randomized, double-blind, placebo-controlled trial conducted in the
Results
The Figure (available at www.jpeds.com) is a flow diagram showing the subjects’ progression through the study. Of the 106 children who underwent randomization, 54 were assigned to the probiotic group and 52 were assigned to the placebo group. Baseline demographic and clinical characteristics did not differ between the 2 groups (Table I). The outcome measures are summarized in Table II. We found no difference between the study groups with respect to the incidence of nosocomial diarrhea. Of the
Discussion
This study provides evidence that in hospitalized children, the administration of L reuteri DSM 17938 at a dose 108 CFU per day compared with placebo had no effect on the overall incidence of nosocomial diarrhea, including rotavirus infection.
The strengths of this study include adequate randomization, the use of a double-blind design, comprehensive follow-up, and the use of intention-to-treat analysis, all of which minimize the risk of bias. Considering the negative findings, one limitation of
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This study was funded by the Medical University of Warsaw, which received a donation from the manufacturer of L reuteri DSM 17938, BioGaia AB, Lund, Sweden. The manufacturer had no role in the conception, design, or conduct of the study, or in the analysis or interpretation of the data. The authors declare no conflicts of interest.
Registered at ClinicalTrials.gov: NCT01046656.