Study of Culturelle in the Prophylaxis of Infection and Diarrhea

November 12, 2013 updated by: Michele Gottschlich, Shriners Hospitals for Children

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Shriners Hospital for Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dietary supplement: Placebo
one placebo 2x per day per feeding tube
Experimental: Culturelle
Dietary supplement: Culturelle
one capsule 2x per day per feeding tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infectious outcome
Time Frame: 3 years
Record incidence of infection between the experimental and placebo groups.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical outcome
Time Frame: 3 years
Plan to measure clinical outcome between the experimental and placebo groups.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shriners Hospitals for Children

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

January 1, 2013

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

May 8, 2012

First Submitted That Met QC Criteria

May 23, 2012

First Posted (Estimate)

May 25, 2012

Study Record Updates

Last Update Posted (Estimate)

November 13, 2013

Last Update Submitted That Met QC Criteria

November 12, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-12-13-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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