Lactobacillus Reuteri DSM 17938 in Preventing Nosocomial Diarrhea in Children

Phase 3CompletedNCT01968408

Medical University of Warsaw184 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

184

Conditions

Diarrhea

Interventions

Lactobacillus reuteri DSM 17938DIETARY_SUPPLEMENT

10(9) CFU/daily

PlaceboDIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 1 MonthMax age: 48 Months

Medical Language ↔ Plain English

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)

Locations (1)

Department of Pediatrics, Medical University of Warsaw

Warsaw, Poland

Outcomes

Primary Outcomes

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)

Time frame: Any time starting 72 h after admission

Secondary Outcomes

Incidence of diarrhea- passage of 3 or more loose or watery stools in a 24-h period

Time frame: 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)

Time frame: during hospitalisation (expected average 3-5 days) and 72 h after discharge

Need and the length of intravenous rehydration due to diarrhea

Time frame: During the hospitalization-expected average 3-5 days

Prolongation of the hospitalization due to nosocomial diarrhea

Time frame: during the hospitalization-expected average 3-5 days

Incidence of rotavirus diarrhea (ie, detection of rotavirus or antigen in the stools)

Positive test for rotavirus or antigen in the stool sample

Time frame: 72 hours after admission to the hospital to 72 hours after discharge

Incidence of chronic diarrhea- lasting more than 14 days

Time frame: untill 14 days after onset of diarrhea

Length of hospital stay

Time frame: During hospitalisation-expected average 3-5 days

Adverse effects

Data from ClinicalTrials.gov

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