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Study of Culturelle in the Prophylaxis of Infection and Diarrhea

NCT ID: NCT01605747

Last Updated: 2013-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2015-12-31

Brief Summary

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

Detailed Description

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Conditions

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Pediatric Burns

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Culturelle

Group Type EXPERIMENTAL

Culturelle

Intervention Type DIETARY_SUPPLEMENT

one capsule 2x per day per feeding tube

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

one placebo 2x per day per feeding tube

Interventions

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Culturelle

one capsule 2x per day per feeding tube

Intervention Type DIETARY_SUPPLEMENT

Placebo

one placebo 2x per day per feeding tube

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shriners Hospitals for Children

OTHER

Sponsor Role lead

Responsible Party

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Michele Gottschlich

Director, Nutrition Services

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shriners Hospital for Children

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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10-12-13-02

Identifier Type: -

Identifier Source: org_study_id