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L Reuteri for the Prevention of Nosocomial Diarrhea

NCT01046656 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2012-01-31

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Lactobacillus reuteri (DSM 17938)

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

Sponsors & Collaborators

  • Medical University of Warsaw

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
48 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2011-06-30
Completion
2011-07-31

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01046656 on ClinicalTrials.gov