Study of Culturelle in the Prophylaxis of Infection and Diarrhea

Phase 2TerminatedNCT01605747

Shriners Hospitals for Children20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Pediatric Burns

Interventions

CulturelleDIETARY_SUPPLEMENT

one capsule 2x per day per feeding tube

PlaceboDIETARY_SUPPLEMENT

one placebo 2x per day per feeding tube

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Shriners Hospital for Children

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

Infectious outcome

Record incidence of infection between the experimental and placebo groups.

Time frame: 3 years

Secondary Outcomes

Clinical outcome

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

Time frame: 3 years

Data from ClinicalTrials.gov

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