Trial record 6 of 1159 for:    diarrhea

Lactobacillus Reuteri DSM 17938 in Preventing Nosocomial Diarrhea in Children

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014