L Reuteri for the Prevention of Nosocomial Diarrhea (PND)

January 27, 2012 updated by: Medical University of Warsaw

Efficacy of Lactobacillus Reuteri DSM 17938 in the Prevention of Nosocomial Diarrhea in Children. Randomized Double-blind Placebo Controlled Trial

Nosocomial diarrhea is any diarrhea that a patient contracts in a health-care institution. In children, it is commonly caused by enteric pathogens, especially rotavirus. The reported incidence ranges from 4.5 to 22.6 episodes per 100 admissions. Nosocomial diarrhea may prolong the hospital stay and increase medical costs. One of the potential strategies for the prevention of nosocomial infections is the use of probiotics. The number of studies have shown the efficacy of Lactobacillus reuteri (DSM 17938) in the treatment of acute diarrhea. However, there are no data on the efficacy of L. reuteri in the prevention of nosocomial diarrhea. The investigators, therefore, plan to perform the study with the aim of evaluating the role of Lactobacillus reuteri DSM 17938 administration in the prevention of nosocomial gastroenteritis in a pediatric hospital setting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Infants will be randomly assigned at admission to receive L. reuteri in dose of 10(8) CFU in 5 drops of oil suspension or a comparable placebo once daily for the entire duration of their hospital stay.

Patients will be evaluated daily for stool number and consistency. In case of loose or watery stools occurring within 3 days after discharge, patients will be advised to contact hospital physicians. Stool samples obtained weekly and during an episode of diarrhea, will be analyzed for bacteria with standard stool cultures and rotavirus and adenovirus antigen.

Study Type

Interventional

Enrollment (Anticipated)

106

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, 01-184
        • The Medical University of Warsaw, Department of Paediatrics

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:

  • age 1-48 mo
  • cause of hospitalization must be other than acute gastroenteritis or diarrhea

Exclusion Criteria:

  • acute gastroenteritis within 3 days before admission
  • other symptoms which suggest gastroenteritis
  • usage of probiotics and/or prebiotics within 7 days before admission
  • visible blood in the stool
  • patient in bad condition
  • lack of approval from patients parents
  • breastfeeding
  • no compliance

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Nosocomial diarrhea (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: from 72nd hrs till the and of hospitalization no longer than 14 days
from 72nd hrs till the and of hospitalization no longer than 14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Length of hospital stay in days
Time Frame: from 72nd hrs till the and of hospitalization no longer than 14 days
from 72nd hrs till the and of hospitalization no longer than 14 days
Recurrent diarrhea - recurrence of diarrhea after 48h of normal stools
Time Frame: from 72nd hrs till the and of hospitalization no longer than 14 days
from 72nd hrs till the and of hospitalization no longer than 14 days
Chronic diarrhea - diarrhea beyond 14 days
Time Frame: from 72nd hrs till the and of hospitalization no longer than 14 days
from 72nd hrs till the and of hospitalization no longer than 14 days
Diarrhea - the passage of 3 or more loose of watery stools in a 24 h period
Time Frame: from 72nd hrs till the and of hospitalization no longer than 14 days
from 72nd hrs till the and of hospitalization no longer than 14 days
Rotavirus infection - detection of rotavirus or antigen in the stools
Time Frame: from 72nd hrs till the and of hospitalization no longer than 14 days
from 72nd hrs till the and of hospitalization no longer than 14 days
Duration of diarrhea - time till the last loose watery stools from the onset of diarrhea measured in days)
Time Frame: from 72nd hrs till the and of hospitalization no longer than 14 days
from 72nd hrs till the and of hospitalization no longer than 14 days
Need for rehydration
Time Frame: from 72nd hrs till the and of hospitalization no longer than 14 days
from 72nd hrs till the and of hospitalization no longer than 14 days

Collaborators and Investigators

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

Sponsor

Medical University of Warsaw

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2009

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

December 16, 2009

First Submitted That Met QC Criteria

January 11, 2010

First Posted (Estimate)

January 12, 2010

Study Record Updates

Last Update Posted (Estimate)

January 31, 2012

Last Update Submitted That Met QC Criteria

January 27, 2012

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 152/2009

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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