Study of Culturelle in the Prophylaxis of Infection and Diarrhea

Pediatric Burns Clinical Trial

Official title:

A Blinded Placebo Controlled Clinical Outcomes Study of Culturelle® in the Prophylaxis of Infection and Diarrhea

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01605747
• Other study ID #: 10-12-13-02
• Status: Terminated
• Phase: Phase 2
• First received: May 8, 2012
• Last updated: November 12, 2013
• Start date: January 2011
• Est. completion date: December 2015

Study information

• Verified date: November 2013
• Source: Shriners Hospitals for Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: December 2015
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pediatric Burns

Intervention

Dietary Supplement:
• Culturelle
one capsule 2x per day per feeding tube
• Placebo
one placebo 2x per day per feeding tube

Locations

Country	Name	City	State
United States	Shriners Hospital for Children	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Shriners Hospitals for Children

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infectious outcome	Record incidence of infection between the experimental and placebo groups.	3 years	Yes
Secondary	Clinical outcome	Plan to measure clinical outcome between the experimental and placebo groups.	3 years	Yes