Lactobacillus Reuteri DSM 17938 in Preventing Nosocomial Diarrhea in Children

NCT01968408 | Completed Phase 3 DMC

• 1 other identifier: KB/125/2012
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Diarrhea

Keywords

nosocomial diarrhea; Lactobacillus reuteri DSM 17938; rotavirus diarrhea; probiotics

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• 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

• 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

• Need and the length of intravenous rehydration due to diarrhea

  During the hospitalization-expected average 3-5 days

• Prolongation of the hospitalization due to nosocomial diarrhea

  during the hospitalization-expected average 3-5 days

• Incidence of rotavirus diarrhea (ie, detection of rotavirus or antigen in the stools)

  72 hours after admission to the hospital to 72 hours after discharge

Study Arms (2)

L. reuteri DSM 17938

ACTIVE COMPARATOR

Lactobacillus reuteri DSM 17938,10(9)CFU/daily (for the duration of hospitalization) ARM I: Rotavirus vaccinated patients ARM II: Non-rotavirus vaccinated patients

Dietary Supplement: Lactobacillus reuteri DSM 17938

Placebo

PLACEBO COMPARATOR

Placebo consists of an identical formulation in all respects except that the live probiotic bacteria were excluded for the duration of hospitalization

Dietary Supplement: Placebo

Interventions

Lactobacillus reuteri DSM 17938 DIETARY_SUPPLEMENT

10(9) CFU/daily

L. reuteri DSM 17938

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 1 Month - 48 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Department of Pediatrics, Medical University of Warsaw

Warsaw, 01-410, Poland

Location

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hanna Szajewska, MD, Profesor

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffesor

Study Record Dates

• First Submitted: September 3, 2012
• First Posted: October 24, 2013
• Study Start: September 1, 2012
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: June 18, 2015

Record last verified: 2015-06

Locations

PL (1)