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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:
ClinicalTrials.gov Identifier:
NCT01605747
First Posted: May 25, 2012
Last Update Posted: November 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Michele Gottschlich, Shriners Hospitals for Children
May 8, 2012
May 25, 2012
November 13, 2013
January 2011
January 2013   (Final data collection date for primary outcome measure)
Infectious outcome [ Time Frame: 3 years ]
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 ]
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Sexes Eligible for Study: All
6 Months to 18 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01605747
10-12-13-02
Not Provided
Not Provided
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