Lactobacillus Reuteri DSM 17938 in Preventing Nosocomial Diarrhea in Children

Phase 3

Completed

• Conditions: Diarrhea
• Interventions: Dietary Supplement: Lactobacillus reuteri DSM 17938; Dietary Supplement: Placebo

• Registration Number: NCT01968408
• Lead Sponsor: Medical University of Warsaw

Brief 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.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-03
• Study First Submitted QC: 2013-10-18
• Study First Posted: 2013-10-24
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-17
• Last Update Posted: 2015-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184

Inclusion Criteria

• Children aged 1-48 mo admitted to the hospital for reasons other than diarrhea
• Signed informed consent.

Exclusion Criteria

• Acute gastroenteritis within 3 days before admission
• Symptoms other than diarrhea suggesting gastroenteritis
• Use of probiotics within 7 days before admission
• Immunodeficiency disorders
• Breastfeeding >50%
• Underlying gastrointestinal tract disorder
• Malnutrition (weight/high <3pc)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
L. reuteri DSM 17938	Lactobacillus reuteri DSM 17938	Lactobacillus reuteri DSM 17938,10(9)CFU/daily (for the duration of hospitalization) ARM I: Rotavirus vaccinated patients ARM II: Non-rotavirus vaccinated patients
Placebo	Placebo	Placebo consists of an identical formulation in all respects except that the live probiotic bacteria were excluded for the duration of hospitalization

Primary Outcome Measures

Name	Time	Method
Incidence of nosocomial diarrhea (defined as the passage of 3 or more loose or watery stools in a 24-hour period that will occur more than 72 hours after admission)	Any time starting 72 h after admission

Secondary Outcome Measures

Name	Time	Method
Incidence of rotavirus diarrhea (ie, detection of rotavirus or antigen in the stools)	72 hours after admission to the hospital to 72 hours after discharge	Positive test for rotavirus or antigen in the stool sample
Adverse effects	During hospitalisation (expected average 3-5 days) plus 72 h after discharge
Incidence of diarrhea- passage of 3 or more loose or watery stools in a 24-h period	from the time of admission to the time of discharge of the hospital-expected average 3-5 days
Duration of diarrhea (ie, time till the last loose or watery stool from the onset of diarrhea)	during hospitalisation (expected average 3-5 days) and 72 h after discharge
Need and the length of intravenous rehydration due to diarrhea	During the hospitalization-expected average 3-5 days
Prolongation of the hospitalization due to nosocomial diarrhea	during the hospitalization-expected average 3-5 days
Incidence of chronic diarrhea- lasting more than 14 days	untill 14 days after onset of diarrhea
Length of hospital stay	During hospitalisation-expected average 3-5 days

Trial Locations

Locations (1)

Department of Pediatrics, Medical University of Warsaw; 🇵🇱 Warsaw, Poland