Lactobacillus Reuteri DSM 17938 in Preventing Nosocomial Diarrhea in Children

June 17, 2015 updated by: Hanna Szajewska, Medical University of Warsaw

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

184

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Warsaw, Poland, 01-410
        • Department of Pediatrics, Medical University of Warsaw

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: L. 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
Dietary supplement: Lactobacillus reuteri DSM 17938
10(9) CFU/daily
Placebo Comparator: Placebo

Placebo consists of an identical formulation in all respects except that the live probiotic bacteria were excluded

for the duration of hospitalization
Dietary supplement: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Any time starting 72 h after admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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
during the hospitalization-expected average 3-5 days
Incidence of rotavirus diarrhea (ie, detection of rotavirus or antigen in the stools)
Time Frame: 72 hours after admission to the hospital to 72 hours after discharge
Positive test for rotavirus or antigen in the stool sample
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
untill 14 days after onset of diarrhea
Length of hospital stay
Time Frame: During hospitalisation-expected average 3-5 days
During hospitalisation-expected average 3-5 days
Adverse effects
Time Frame: During hospitalisation (expected average 3-5 days) plus 72 h after discharge
During hospitalisation (expected average 3-5 days) plus 72 h after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Investigators

  • Principal Investigator: Hanna Szajewska, MD, Profesor, Medical University of Warsaw

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

September 3, 2012

First Submitted That Met QC Criteria

October 18, 2013

First Posted (Estimate)

October 24, 2013

Study Record Updates

Last Update Posted (Estimate)

June 18, 2015

Last Update Submitted That Met QC Criteria

June 17, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KB/125/2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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