Study of Culturelle in the Prophylaxis of Infection and Diarrhea

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01605747

Enrollment

Registered

2012-05-25

Start date

2011-01-31

Completion date

2015-12-31

Last updated

2013-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Burns

Brief summary

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

Interventions

DIETARY_SUPPLEMENTCulturelle

one capsule 2x per day per feeding tube

DIETARY_SUPPLEMENTPlacebo

one placebo 2x per day per feeding tube

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Months to 18 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026