L Reuteri for the Prevention of Nosocomial Diarrhea

Diarrhea Clinical Trial

— PND  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01046656
• Other study ID #: 152/2009
• Secondary ID: 152/2009
• Status: Completed
• Phase: Phase 3
• First received: December 16, 2009
• Last updated: January 27, 2012
• Start date: December 2009
• Est. completion date: July 2011

Study information

• Verified date: December 2009
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: July 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 48 Months

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cross Infection
• Diarrhea
• Gastroenteritis
• Nosocomial Infection

Intervention

Dietary Supplement:
• Lactobacillus reuteri (DSM 17938)
5 drops once daily (10(8) CFU) for the entire duration of hospital stay

Locations

Country	Name	City	State
Poland	The Medical University of Warsaw, Department of Paediatrics	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Length of hospital stay in days		from 72nd hrs till the and of hospitalization no longer than 14 days	Yes
Secondary	Recurrent diarrhea - recurrence of diarrhea after 48h of normal stools		from 72nd hrs till the and of hospitalization no longer than 14 days	Yes
Secondary	Chronic diarrhea - diarrhea beyond 14 days		from 72nd hrs till the and of hospitalization no longer than 14 days	Yes
Secondary	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	Yes
Secondary	Rotavirus infection - detection of rotavirus or antigen in the stools		from 72nd hrs till the and of hospitalization no longer than 14 days	Yes
Secondary	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	Yes
Secondary	Need for rehydration		from 72nd hrs till the and of hospitalization no longer than 14 days	Yes