Study of Culturelle in the Prophylaxis of Infection and Diarrhea

Phase 2

Terminated

• Conditions: Pediatric Burns
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Culturelle

• Registration Number: NCT01605747
• Lead Sponsor: Shriners Hospitals for Children

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2012-05-08
• Study First Submitted QC: 2012-05-23
• Study First Posted: 2012-05-25
• Primary Completion: 2013-01
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-12
• Last Update Posted: 2013-11-13
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Culturelle	Culturelle	-

Primary Outcome Measures

Name	Time	Method
Infectious outcome	3 years	Record incidence of infection between the experimental and placebo groups.

Secondary Outcome Measures

Name	Time	Method
Clinical outcome	3 years	Plan to measure clinical outcome between the experimental and placebo groups.

Trial Locations

Locations (1)

Shriners Hospital for Children; 🇺🇸 Cincinnati, Ohio, United States