Clinical trial NCT01046656: L Reuteri for the Prevention of Nosocomial Diarrhea
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nosocomial Infection
Diarrhea
Gastroenteritis
Keywords: nosocomial infection
diarrhea
Lactobacillus reuteri
gastroenteritis
rotavirus
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2010-01-12
Enrollment: 106
Sex: ALL
Minimum age (years): 1
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: 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)
timeFrame: from 72nd hrs till the and of hospitalization no longer than 14 days
Secondary outcomes:
measure: Length of hospital stay in days
timeFrame: from 72nd hrs till the and of hospitalization no longer than 14 days
measure: Recurrent diarrhea - recurrence of diarrhea after 48h of normal stools
timeFrame: from 72nd hrs till the and of hospitalization no longer than 14 days
measure: Chronic diarrhea - diarrhea beyond 14 days
timeFrame: from 72nd hrs till the and of hospitalization no longer than 14 days
measure: Diarrhea - the passage of 3 or more loose of watery stools in a 24 h period
timeFrame: from 72nd hrs till the and of hospitalization no longer than 14 days
measure: Rotavirus infection - detection of rotavirus or antigen in the stools
timeFrame: from 72nd hrs till the and of hospitalization no longer than 14 days
measure: Duration of diarrhea - time till the last loose watery stools from the onset of diarrhea measured in days)
timeFrame: from 72nd hrs till the and of hospitalization no longer than 14 days
measure: Need for rehydration
timeFrame: from 72nd hrs till the and of hospitalization no longer than 14 days
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: The Medical University of Warsaw, Department of Paediatrics
Study officials:
References:
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.