L Reuteri for the Prevention of Nosocomial Diarrhea - Full Text View

Sponsor:	Medical University of Warsaw
Information provided by:	Medical University of Warsaw
ClinicalTrials.gov Identifier:	NCT01046656

Purpose

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	Intervention	Phase
Nosocomial Infection Diarrhea Gastroenteritis	Dietary Supplement: Lactobacillus reuteri (DSM 17938)	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Bowel Movement Diarrhea Gastroenteritis

Drug Information available for: Lactobacillus

U.S. FDA Resources

Further study details as provided by Medical University of Warsaw:

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) [ Time Frame: from 72nd hrs till the and of hospitalization no longer than 14 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Length of hospital stay in days [ Time Frame: from 72nd hrs till the and of hospitalization no longer than 14 days ] [ Designated as safety issue: Yes ]
Recurrent diarrhea - recurrence of diarrhea after 48h of normal stools [ Time Frame: from 72nd hrs till the and of hospitalization no longer than 14 days ] [ Designated as safety issue: Yes ]
Chronic diarrhea - diarrhea beyond 14 days [ Time Frame: from 72nd hrs till the and of hospitalization no longer than 14 days ] [ Designated as safety issue: Yes ]
Diarrhea - the passage of 3 or more loose of watery stools in a 24 h period [ Time Frame: from 72nd hrs till the and of hospitalization no longer than 14 days ] [ Designated as safety issue: Yes ]
Rotavirus infection - detection of rotavirus or antigen in the stools [ Time Frame: from 72nd hrs till the and of hospitalization no longer than 14 days ] [ Designated as safety issue: Yes ]
Duration of diarrhea - time till the last loose watery stools from the onset of diarrhea measured in days) [ Time Frame: from 72nd hrs till the and of hospitalization no longer than 14 days ] [ Designated as safety issue: Yes ]
Need for rehydration [ Time Frame: from 72nd hrs till the and of hospitalization no longer than 14 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	106
Study Start Date:	December 2009
Study Completion Date:	July 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Intervention Details:

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

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

Ages Eligible for Study:	1 Month to 48 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01046656

Locations

Poland
The Medical University of Warsaw, Department of Paediatrics
Warsaw, Poland, 01-184

Sponsors and Collaborators

Medical University of Warsaw

More Information

No publications provided

Responsible Party:	Hania Szajewska, Department of Paediatrics, The Medical University of Warsaw
ClinicalTrials.gov Identifier:	NCT01046656 History of Changes
Other Study ID Numbers:	152/2009, 152/2009
Study First Received:	December 16, 2009
Last Updated:	January 27, 2012
Health Authority:	Poland: Ethics Committee

Keywords provided by Medical University of Warsaw:

nosocomial infection
diarrhea
Lactobacillus reuteri
gastroenteritis
rotavirus

Additional relevant MeSH terms:

Diarrhea
Gastroenteritis
Cross Infection
Signs and Symptoms, Digestive

Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases
Infection

ClinicalTrials.gov processed this record on May 23, 2012