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Lactobacillus Reuteri DSM 17938 in Preventing Nosocomial Diarrhea in Children

Primary Purpose

Diarrhea

Status
Completed
Phase
Phase 3
Locations
Poland
Study Type
Interventional
Intervention
Lactobacillus reuteri DSM 17938
Placebo
Sponsored by
Medical University of Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diarrhea focused on measuring nosocomial diarrhea, Lactobacillus reuteri DSM 17938, rotavirus diarrhea, probiotics

Eligibility Criteria

1 Month - 48 Months (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Department of Pediatrics, Medical University of Warsaw

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

L. reuteri DSM 17938

Placebo

Arm Description

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Incidence of diarrhea- passage of 3 or more loose or watery stools in a 24-h period
Duration of diarrhea (ie, time till the last loose or watery stool from the onset of diarrhea)
Need and the length of intravenous rehydration due to diarrhea
Prolongation of the hospitalization due to nosocomial diarrhea
Incidence of rotavirus diarrhea (ie, detection of rotavirus or antigen in the stools)
Positive test for rotavirus or antigen in the stool sample
Incidence of chronic diarrhea- lasting more than 14 days
Length of hospital stay
Adverse effects

Full Information

First Posted
September 3, 2012
Last Updated
June 17, 2015
Sponsor
Medical University of Warsaw
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1. Study Identification

Unique Protocol Identification Number
NCT01968408
Brief Title
Lactobacillus Reuteri DSM 17938 in Preventing Nosocomial Diarrhea in Children
Official Title
Effectiveness of Lactobacillus Reuteri DSM 17938 in Preventing Nosocomial Diarrhea in Children: a Randomized, Double-blind Placebo Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Warsaw

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea
Keywords
nosocomial diarrhea, Lactobacillus reuteri DSM 17938, rotavirus diarrhea, probiotics

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
184 (Actual)

8. Arms, Groups, and Interventions

Arm Title
L. reuteri DSM 17938
Arm Type
Active Comparator
Arm Description
Lactobacillus reuteri DSM 17938,10(9)CFU/daily (for the duration of hospitalization) ARM I: Rotavirus vaccinated patients ARM II: Non-rotavirus vaccinated patients
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo consists of an identical formulation in all respects except that the live probiotic bacteria were excluded for the duration of hospitalization
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus reuteri DSM 17938
Intervention Description
10(9) CFU/daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
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
Title
Need and the length of intravenous rehydration due to diarrhea
Time Frame
During the hospitalization-expected average 3-5 days
Title
Prolongation of the hospitalization due to nosocomial diarrhea
Time Frame
during the hospitalization-expected average 3-5 days
Title
Incidence of rotavirus diarrhea (ie, detection of rotavirus or antigen in the stools)
Description
Positive test for rotavirus or antigen in the stool sample
Time Frame
72 hours after admission to the hospital to 72 hours after discharge
Title
Incidence of chronic diarrhea- lasting more than 14 days
Time Frame
untill 14 days after onset of diarrhea
Title
Length of hospital stay
Time Frame
During hospitalisation-expected average 3-5 days
Title
Adverse effects
Time Frame
During hospitalisation (expected average 3-5 days) plus 72 h after discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
48 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanna Szajewska, MD, Profesor
Organizational Affiliation
Medical University of Warsaw
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pediatrics, Medical University of Warsaw
City
Warsaw
ZIP/Postal Code
01-410
Country
Poland

12. IPD Sharing Statement

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Lactobacillus Reuteri DSM 17938 in Preventing Nosocomial Diarrhea in Children

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