Study of Culturelle in the Prophylaxis of Infection and Diarrhea

This study has been terminated.
(Study was stopped due to inavailability of subjects meeting eligibility criteria.)
Sponsor:
Information provided by (Responsible Party):
Michele Gottschlich, Shriners Hospitals for Children
ClinicalTrials.gov Identifier:
NCT01605747
First received: May 8, 2012
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

The primary objective of this study is to determine if probiotic prophylaxis has immunologic and gastrointestinal advantages in pediatric burn patients.


Condition Intervention Phase
Pediatric Burns
Dietary Supplement: Culturelle
Dietary Supplement: Placebo
Phase 2

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: A Blinded Placebo Controlled Clinical Outcomes Study of Culturelle® in the Prophylaxis of Infection and Diarrhea

Resource links provided by NLM:


Further study details as provided by Shriners Hospitals for Children:

Primary Outcome Measures:
  • Infectious outcome [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Record incidence of infection between the experimental and placebo groups.


Secondary Outcome Measures:
  • Clinical outcome [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Plan to measure clinical outcome between the experimental and placebo groups.


Enrollment: 20
Study Start Date: January 2011
Estimated Study Completion Date: December 2015
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Culturelle Dietary Supplement: Culturelle
one capsule 2x per day per feeding tube
Placebo Comparator: Placebo Dietary Supplement: Placebo
one placebo 2x per day per feeding tube

  Eligibility

Ages Eligible for Study:   6 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • acute burn injury
  • consented within 10 days of injury
  • feeding tube present-

Exclusion Criteria:

  • GI disorder prior to burn
  • milk allergy or insensitivity
  • non-burned
  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: NCT01605747

Locations
United States, Ohio
Shriners Hospital for Children
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Shriners Hospitals for Children
  More Information

No publications provided

Responsible Party: Michele Gottschlich, Director, Nutrition Services, Shriners Hospitals for Children
ClinicalTrials.gov Identifier: NCT01605747     History of Changes
Other Study ID Numbers: 10-12-13-02
Study First Received: May 8, 2012
Last Updated: November 12, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 23, 2014