NCT01046656

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2009

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 12, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

January 31, 2012

Status Verified

December 1, 2009

Enrollment Period

1.5 years

First QC Date

December 16, 2009

Last Update Submit

January 27, 2012

Conditions

Nosocomial InfectionDiarrheaGastroenteritis

Keywords

nosocomial infectiondiarrheaLactobacillus reuterigastroenteritisrotavirus

Outcome Measures

Primary Outcomes (1)

  • 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)

    from 72nd hrs till the and of hospitalization no longer than 14 days

Secondary Outcomes (7)

  • Length of hospital stay in days

    from 72nd hrs till the and of hospitalization no longer than 14 days

  • Recurrent diarrhea - recurrence of diarrhea after 48h of normal stools

    from 72nd hrs till the and of hospitalization no longer than 14 days

  • Chronic diarrhea - diarrhea beyond 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

    from 72nd hrs till the and of hospitalization no longer than 14 days

  • Rotavirus infection - detection of rotavirus or antigen in the stools

    from 72nd hrs till the and of hospitalization no longer than 14 days

  • +2 more secondary outcomes

Interventions

Lactobacillus reuteri (DSM 17938)DIETARY_SUPPLEMENT

5 drops once daily (10(8) CFU) for the entire duration of hospital stay

Eligibility Criteria

Age1 Month - 48 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Medical University of Warsaw, Department of Paediatrics

Warsaw, 01-184, Poland

Location

Related Publications (1)

  • 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.

    PMID: 22306046DERIVED

MeSH Terms

Conditions

Cross InfectionDiarrheaGastroenteritis

Condition Hierarchy (Ancestors)

InfectionsIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveSigns and SymptomsGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 16, 2009

First Posted

January 12, 2010

Study Start

December 1, 2009

Primary Completion

June 1, 2011

Study Completion

July 1, 2011

Last Updated

January 31, 2012

Record last verified: 2009-12

Locations

PL(1)