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Effectiveness of Lactobacillus reuteri DSM 17938 for the Prevention of Nosocomial Diarrhea in Children

A Randomized, Double-blind, Placebo-controlled Trial

Urbańska, Magdalena MD*; Gieruszczak–Białek, Dorota MD*; Szymański, Henryk MD; Szajewska, Hania MD*

The Pediatric Infectious Disease Journal: February 2016 - Volume 35 - Issue 2 - p 142–145
doi: 10.1097/INF.0000000000000948
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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.

From the *Department of Paediatrics, The Medical University of Warsaw, Poland; and Department of Paediatrics, St Hedvig of Silesia Hospital, Trzebnica, Poland.

Accepted for publication August 26, 2015.

This study was fully funded by the Medical University of Warsaw. The study products (Lactobacillus reuteri DSM 17938 and placebo) were manufactured and supplied by BioGaia (Lund, Sweden) free of charge. The manufacturer had no role in the conception, protocol development, design or conduct of the study, or in the analysis or interpretation of the data. H. Szajewska served as a speaker for BioGaia. The authors have no conflicts of interest to disclose.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s website (www.pidj.com).

Address for correspondence: Hania Szajewska, MD, Department of Paediatrics, The Medical University of Warsaw, 02-091 Warsaw, Zwirki i Wigury 63A, Poland. E-mail: hania@ipgate.pl.

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