Lactobacillus Reuteri DSM 17938 in Preventing Nosocomial Diarrhea in Children

Diarrhea Clinical Trial

Official title:

Effectiveness of Lactobacillus Reuteri DSM 17938 in Preventing Nosocomial Diarrhea in Children: a Randomized, Double-blind Placebo Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01968408
• Other study ID #: KB/125/2012
• Status: Completed
• Phase: Phase 3
• First received: September 3, 2012
• Last updated: June 17, 2015
• Start date: September 2012
• Est. completion date: February 2015

Study information

• Verified date: June 2015
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

AIM: To determine the efficacy of Lactobacillus reuteri DSM 17938 at a dose of 10(9) CFU for the prevention of nosocomial diarrhea.

TRIAL DESIGN: Double-blind, placebo controlled RCT. INTERVENTION: L reuteri DSM 17938 in a daily dose of 10(9) CFU. PRIMARY OUTCOME: Nosocomial diarrhoea (3 or more loose or watery stools in a 24 h that will occur more than 72 h after admission).

Description:

Nosocomial diarrhea is a common problem in hospitalized children. Previously, it has been documented that the administration of L reuteri DSM 17938 at a dose of 10(8) colony forming units (CFU) compared with placebo had no effect on the overall incidence of nosocomial diarrhea (Wanke & Szajewska, J Pediatr 2012). Whether higher doses of L reuteri DSM 17938 have such effects needs to be substantiated in further randomized trials.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 48 Months

Eligibility

Inclusion Criteria:

• Children aged 1-48 mo admitted to the hospital for reasons other than diarrhea

• Signed informed consent.

Exclusion Criteria:

• Acute gastroenteritis within 3 days before admission

• Symptoms other than diarrhea suggesting gastroenteritis

• Use of probiotics within 7 days before admission

• Immunodeficiency disorders

• Breastfeeding >50%

• Underlying gastrointestinal tract disorder

• Malnutrition (weight/high <3pc)

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

• Diarrhea

Intervention

Dietary Supplement:
• Lactobacillus reuteri DSM 17938
10(9) CFU/daily
• Placebo

Locations

Country	Name	City	State
Poland	Department of Pediatrics, Medical University of Warsaw	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	Incidence of nosocomial diarrhea (defined as the passage of 3 or more loose or watery stools in a 24-hour period that will occur more than 72 hours after admission)		Any time starting 72 h after admission	No
Secondary	Incidence of diarrhea- passage of 3 or more loose or watery stools in a 24-h period		from the time of admission to the time of discharge of the hospital-expected average 3-5 days	No
Secondary	Duration of diarrhea (ie, time till the last loose or watery stool from the onset of diarrhea)		during hospitalisation (expected average 3-5 days) and 72 h after discharge	No
Secondary	Need and the length of intravenous rehydration due to diarrhea		During the hospitalization-expected average 3-5 days	No
Secondary	Prolongation of the hospitalization due to nosocomial diarrhea		during the hospitalization-expected average 3-5 days	No
Secondary	Incidence of rotavirus diarrhea (ie, detection of rotavirus or antigen in the stools)	Positive test for rotavirus or antigen in the stool sample	72 hours after admission to the hospital to 72 hours after discharge	No
Secondary	Incidence of chronic diarrhea- lasting more than 14 days		untill 14 days after onset of diarrhea	No
Secondary	Length of hospital stay		During hospitalisation-expected average 3-5 days	No
Secondary	Adverse effects		During hospitalisation (expected average 3-5 days) plus 72 h after discharge	Yes