NCT01968408

Lactobacillus Reuteri DSM 17938 in Preventing Nosocomial Diarrhea in Children

Effectiveness of Lactobacillus Reuteri DSM 17938 in Preventing Nosocomial Diarrhea in Children: a Randomized, Double-blind Placebo Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 184 (actual)
• Sponsor: Medical University of Warsaw · Academic / Other
• Sex: All
• Age: 1 Month – 48 Months
• Healthy volunteers: Not accepted

Summary

AIM: To determine the efficacy of Lactobacillus reuteri DSM 17938 at a dose of 10(9) CFU for the prevention of nosocomial diarrhea. TRIAL DESIGN: Double-blind, placebo controlled RCT. INTERVENTION: L reuteri DSM 17938 in a daily dose of 10(9) CFU. PRIMARY OUTCOME: Nosocomial diarrhoea (3 or more loose or watery stools in a 24 h that will occur more than 72 h after admission).

Detailed description

Nosocomial diarrhea is a common problem in hospitalized children. Previously, it has been documented that the administration of L reuteri DSM 17938 at a dose of 10(8) colony forming units (CFU) compared with placebo had no effect on the overall incidence of nosocomial diarrhea (Wanke \& Szajewska, J Pediatr 2012). Whether higher doses of L reuteri DSM 17938 have such effects needs to be substantiated in further randomized trials.

Conditions

• Diarrhea

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lactobacillus reuteri DSM 17938	10(9) CFU/daily
DIETARY_SUPPLEMENT	Placebo

Timeline

• Start date: 2012-09-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2013-10-24
• Last updated: 2015-06-18

Locations

1 site across 1 country: Poland