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Study of Culturelle in the Prophylaxis of Infection and Diarrhea

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.
ClinicalTrials.gov Identifier: NCT01605747
Recruitment Status : Terminated (Study was stopped due to inavailability of subjects meeting eligibility criteria.)
First Posted : May 25, 2012
Last Update Posted : November 13, 2013
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Pediatric Burns Dietary Supplement: Culturelle Dietary Supplement: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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
Study Start Date : January 2011
Primary Completion Date : January 2013
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns Diarrhea
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

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

Secondary Outcome Measures :
  1. Clinical outcome [ Time Frame: 3 years ]
    Plan to measure clinical outcome between the experimental and placebo groups.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 Posted: May 25, 2012    Key Record Dates
Last Update Posted: November 13, 2013
Last Verified: November 2013

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