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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.)
Information provided by (Responsible Party):
Michele Gottschlich, Shriners Hospitals for Children Identifier:
First received: May 8, 2012
Last updated: November 12, 2013
Last verified: November 2013
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: Double Blind (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 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


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
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Please refer to this study by its identifier: 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 Identifier: NCT01605747     History of Changes
Other Study ID Numbers: 10-12-13-02
Study First Received: May 8, 2012
Last Updated: November 12, 2013

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms processed this record on May 24, 2017