Original Article
Lack of an Effect of Lactobacillus reuteri DSM 17938 in Preventing Nosocomial Diarrhea in Children: A Randomized, Double-Blind, Placebo-Controlled Trial

https://doi.org/10.1016/j.jpeds.2011.12.049Get rights and content

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 108 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.

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

References (17)

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    Sufficient evidence exists for showing that LGG administrated in a dose of at least 109 CFU per day during a hospital stay can significantly reduce the risk for nosocomial diarrhoea on a regular paediatric ward.28 Evidence of effectiveness of L reuteri DSM17938 in preventing nosocomial diarrhoea in children is absent.25,26 On the basis of currently available evidence, LGG can be recommended when the use of probiotics for preventing nosocomial diarrhoea in children is considered, as recommended by the Working Group on Probiotics from the European Society of Paediatric Gastroenterology, Hepatology and Nutrition.29,30

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    With regard to diarrhoeal diseases, the effective dosing remains unclear. Two earlier studies carried out by our group that evaluated the efficacy of using L. reuteri DSM 17938 at different doses (108 and 109 CFU/day, respectively) showed no effect in preventing nosocomial diarrhoea in children [24,25]. However, other studies have documented the effectiveness of L. reuteri DSM 17938 at a dose of 108 CFU/day both in the management of diarrhoeal diseases and other indications [26–28].

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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.

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