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L Reuteri for the Prevention of Nosocomial Diarrhea (PND)

Primary Purpose

Nosocomial Infection, Diarrhea, Gastroenteritis

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

About this trial

This is an interventional prevention trial for Nosocomial Infection focused on measuring nosocomial infection, diarrhea, Lactobacillus reuteri, gastroenteritis, rotavirus

Eligibility Criteria

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

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

Sites / Locations

  • The Medical University of Warsaw, Department of Paediatrics

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Length of hospital stay in days
Recurrent diarrhea - recurrence of diarrhea after 48h of normal stools
Chronic diarrhea - diarrhea beyond 14 days
Diarrhea - the passage of 3 or more loose of watery stools in a 24 h period
Rotavirus infection - detection of rotavirus or antigen in the stools
Duration of diarrhea - time till the last loose watery stools from the onset of diarrhea measured in days)
Need for rehydration

Full Information

First Posted
December 16, 2009
Last Updated
January 27, 2012
Sponsor
Medical University of Warsaw
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1. Study Identification

Unique Protocol Identification Number
NCT01046656
Brief Title
L Reuteri for the Prevention of Nosocomial Diarrhea
Acronym
PND
Official Title
Efficacy of Lactobacillus Reuteri DSM 17938 in the Prevention of Nosocomial Diarrhea in Children. Randomized Double-blind Placebo Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medical University of Warsaw

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nosocomial Infection, Diarrhea, Gastroenteritis
Keywords
nosocomial infection, diarrhea, Lactobacillus reuteri, gastroenteritis, rotavirus

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus reuteri (DSM 17938)
Intervention Description
5 drops once daily (10(8) CFU) for the entire duration of hospital stay
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Length of hospital stay in days
Time Frame
from 72nd hrs till the and of hospitalization no longer than 14 days
Title
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
Title
Chronic diarrhea - diarrhea beyond 14 days
Time Frame
from 72nd hrs till the and of hospitalization no longer than 14 days
Title
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
Title
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
Title
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
Title
Need for rehydration
Time Frame
from 72nd hrs till the and of hospitalization no longer than 14 days

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: 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
Facility Information:
Facility Name
The Medical University of Warsaw, Department of Paediatrics
City
Warsaw
ZIP/Postal Code
01-184
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
22306046
Citation
Wanke M, Szajewska H. Lack of an effect of Lactobacillus reuteri DSM 17938 in preventing nosocomial diarrhea in children: a randomized, double-blind, placebo-controlled trial. J Pediatr. 2012 Jul;161(1):40-3.e1. doi: 10.1016/j.jpeds.2011.12.049. Epub 2012 Feb 4.
Results Reference
derived

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L Reuteri for the Prevention of Nosocomial Diarrhea

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