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Study of Culturelle in the Prophylaxis of Infection and Diarrhea

Primary Purpose

Pediatric Burns

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Culturelle
Placebo
Sponsored by
Shriners Hospitals for Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pediatric Burns

Eligibility Criteria

6 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shriners Hospital for Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Culturelle

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Infectious outcome
Record incidence of infection between the experimental and placebo groups.

Secondary Outcome Measures

Clinical outcome
Plan to measure clinical outcome between the experimental and placebo groups.

Full Information

First Posted
May 8, 2012
Last Updated
November 12, 2013
Sponsor
Shriners Hospitals for Children
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1. Study Identification

Unique Protocol Identification Number
NCT01605747
Brief Title
Study of Culturelle in the Prophylaxis of Infection and Diarrhea
Official Title
A Blinded Placebo Controlled Clinical Outcomes Study of Culturelle® in the Prophylaxis of Infection and Diarrhea
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Terminated
Why Stopped
Study was stopped due to inavailability of subjects meeting eligibility criteria.
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shriners Hospitals for Children

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Burns

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Culturelle
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Culturelle
Intervention Description
one capsule 2x per day per feeding tube
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
one placebo 2x per day per feeding tube
Primary Outcome Measure Information:
Title
Infectious outcome
Description
Record incidence of infection between the experimental and placebo groups.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Clinical outcome
Description
Plan to measure clinical outcome between the experimental and placebo groups.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Shriners Hospital for Children
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of Culturelle in the Prophylaxis of Infection and Diarrhea

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