L Reuteri for the Prevention of Nosocomial Diarrhea

Phase 3

Completed

• Conditions: Diarrhea; Gastroenteritis; Nosocomial Infection

• Registration Number: NCT01046656
• Lead Sponsor: Medical University of Warsaw

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.

Study Timeline

• Status Verified: 2009-12
• Study Start: 2009-12
• Study First Submitted: 2009-12-16
• Study First Submitted QC: 2010-01-11
• Study First Posted: 2010-01-12
• Primary Completion: 2011-06
• Study Completion: 2011-07
• Last Update Submitted: 2012-01-27
• Last Update Posted: 2012-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Duration of diarrhea - time till the last loose watery stools from the onset of diarrhea measured in days)	from 72nd hrs till the and of hospitalization no longer than 14 days
Need for rehydration	from 72nd hrs till the and of hospitalization no longer than 14 days

Trial Locations

Locations (1)

The Medical University of Warsaw, Department of Paediatrics; 🇵🇱 Warsaw, Poland