PND: L Reuteri for the Prevention of Nosocomial Diarrhea

Sponsor

Medical University of Warsaw (Other)

Overall Status

Completed

CT.gov ID

NCT01046656

Collaborator

(none)

106

Enrollment

Location

Duration (Months)

5.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Nosocomial Infection Diarrhea Gastroenteritis	Dietary Supplement: Lactobacillus reuteri (DSM 17938)	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

106 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Efficacy of Lactobacillus Reuteri DSM 17938 in the Prevention of Nosocomial Diarrhea in Children. Randomized Double-blind Placebo Controlled Trial

Study Start Date :

Dec 1, 2009

Actual Primary Completion Date :

Jun 1, 2011

Actual Study Completion Date :

Jul 1, 2011

Outcome Measures

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

Secondary Outcome Measures

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]