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Study of Culturelle in the Prophylaxis of Infection and Diarrhea

This study is currently recruiting participants.
Verified December 2012 by Shriners Hospitals for Children
Sponsor:
Information provided by (Responsible Party):
Michele Gottschlich, Shriners Hospitals for Children
ClinicalTrials.gov Identifier:
NCT01605747
First received: May 8, 2012
Last updated: December 12, 2012
Last verified: December 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

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

Further study details as provided by Shriners Hospitals for Children:

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


Secondary Outcome Measures:
  • Clinical outcome [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Plan to measure clinical outcome between the experimental and placebo groups.


Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Primary Completion Date: January 2014 (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

Ages Eligible for Study:   6 Months to 18 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01605747

Contacts
Contact: Michele Gottschlich, PhD 513-872-6298 mgottschlich@shrinenet.org

Locations
United States, Ohio
Shriners Hospital for Children Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Michele Gottschlich, PhD     513-872-6298     mgottschlich@shrinenet.org    
Sponsors and Collaborators
Shriners Hospitals for Children
  More Information

No publications provided

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
Study First Received: May 8, 2012
Last Updated: December 12, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2013