We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Michele Gottschlich, Shriners Hospitals for Children:

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


Secondary Outcome Measures:
  • Clinical outcome [ Time Frame: 3 years ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01605747


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

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
First Submitted: May 8, 2012
First Posted: May 25, 2012
Last Update Posted: November 13, 2013
Last Verified: November 2013

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


To Top