Trial record 6 of 1109 for:    diarrhea

Lactobacillus Reuteri DSM 17938 in Preventing Nosocomial Diarrhea in Children

This study is currently recruiting participants.
Verified October 2013 by Medical University of Warsaw
Sponsor:
Information provided by (Responsible Party):
Hanna Szajewska, Medical University of Warsaw
ClinicalTrials.gov Identifier:
NCT01968408
First received: September 3, 2012
Last updated: October 18, 2013
Last verified: October 2013
  Purpose

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).


Condition Intervention Phase
Diarrhea
Dietary Supplement: Lactobacillus reuteri DSM 17938
Dietary Supplement: Placebo
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: Effectiveness of Lactobacillus Reuteri DSM 17938 in Preventing Nosocomial Diarrhea in Children: a Randomized, Double-blind Placebo Controlled Trial

Resource links provided by NLM:


Further study details as provided by Medical University of Warsaw:

Primary Outcome Measures:
  • 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) [ Time Frame: Any time starting 72 h after admission ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of diarrhea- passage of 3 or more loose or watery stools in a 24-h period [ Time Frame: from the time of admission to the time of discharge of the hospital-expected average 3-5 days ] [ Designated as safety issue: No ]
  • Duration of diarrhea (ie, time till the last loose or watery stool from the onset of diarrhea) [ Time Frame: during hospitalisation (expected average 3-5 days) and 72 h after discharge ] [ Designated as safety issue: No ]
  • Need and the length of intravenous rehydration due to diarrhea [ Time Frame: During the hospitalization-expected average 3-5 days ] [ Designated as safety issue: No ]
  • Prolongation of the hospitalization due to nosocomial diarrhea [ Time Frame: during the hospitalization-expected average 3-5 days ] [ Designated as safety issue: No ]
  • Incidence of rotavirus diarrhea (ie, detection of rotavirus or antigen in the stools) [ Time Frame: 72 hours after admission to the hospital to 72 hours after discharge ] [ Designated as safety issue: No ]
    Positive test for rotavirus or antigen in the stool sample

  • Incidence of chronic diarrhea- lasting more than 14 days [ Time Frame: untill 14 days after onset of diarrhea ] [ Designated as safety issue: No ]
  • Length of hospital stay [ Time Frame: During hospitalisation-expected average 3-5 days ] [ Designated as safety issue: No ]
  • Adverse effects [ Time Frame: During hospitalisation (expected average 3-5 days) plus 72 h after discharge ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 106
Study Start Date: September 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: L. reuteri DSM 17938

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
10(9) CFU/daily
Placebo Comparator: Placebo

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

Detailed 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.

  Eligibility

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

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01968408

Contacts
Contact: Magdalena Urbańska, MD +48224523274 magdalena.urb@gmail.com
Contact: Hanna Szajewska, Proffesor +48224523309 hania@ipgate.pl

Locations
Poland
Department of Pediatrics, Medical University of Warsaw Recruiting
Warsaw, Poland, 01-410
Contact: Magdalena Urbańska, MD    +48224523274    magdalena.urb@gmail.com   
Contact: Hanna Szajewska, MD, Profesor    +48224523309    hania@ipgate.pl   
Sponsors and Collaborators
Medical University of Warsaw
Investigators
Principal Investigator: Hanna Szajewska, MD, Profesor Medical University of Warsaw
  More Information

No publications provided

Responsible Party: Hanna Szajewska, Proffesor, Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT01968408     History of Changes
Other Study ID Numbers: KB/125/2012
Study First Received: September 3, 2012
Last Updated: October 18, 2013
Health Authority: Poland: Ethics Committee

Keywords provided by Medical University of Warsaw:
nosocomial diarrhea
Lactobacillus reuteri DSM 17938
rotavirus diarrhea
probiotics

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014