Study of Culturelle in the Prophylaxis of Infection and Diarrhea

Shriners Hospitals for Children

Status and phase: Terminated; Phase 2

Conditions: Pediatric Burns

Treatments: Dietary Supplement: Culturelle; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01605747

10-12-13-02

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 6 months to 18 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

Culturelle

Experimental group

Treatment:

Dietary Supplement: Culturelle

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo