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

May 8, 2012
November 12, 2013
January 2011
January 2013   (final data collection date for primary outcome measure)
Infectious outcome [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Record incidence of infection between the experimental and placebo groups.
Same as current
Complete list of historical versions of study NCT01605747 on ClinicalTrials.gov Archive Site
Clinical outcome [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Plan to measure clinical outcome between the experimental and placebo groups.
Same as current
Not Provided
Not Provided
 
Study of Culturelle in the Prophylaxis of Infection and Diarrhea
A Blinded Placebo Controlled Clinical Outcomes Study of Culturelle® in the Prophylaxis of Infection and Diarrhea

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Pediatric Burns
  • Dietary Supplement: Culturelle
    one capsule 2x per day per feeding tube
  • Dietary Supplement: Placebo
    one placebo 2x per day per feeding tube
  • Experimental: Culturelle
    Intervention: Dietary Supplement: Culturelle
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
20
December 2015
January 2013   (final data collection date for primary outcome measure)

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
Both
6 Months to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01605747
10-12-13-02
Not Provided
Michele Gottschlich, Shriners Hospitals for Children
Shriners Hospitals for Children
Not Provided
Not Provided
Shriners Hospitals for Children
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP