NCT01605747

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2011

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2012

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 25, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

November 13, 2013

Status Verified

November 1, 2013

Enrollment Period

2 years

First QC Date

May 8, 2012

Last Update Submit

November 12, 2013

Conditions

Pediatric Burns

Outcome Measures

Primary Outcomes (1)

  • Infectious outcome

    Record incidence of infection between the experimental and placebo groups.

    3 years

Secondary Outcomes (1)

  • Clinical outcome

    3 years

Study Arms (2)

Culturelle

EXPERIMENTAL
Dietary Supplement: Culturelle

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

CulturelleDIETARY_SUPPLEMENT

one capsule 2x per day per feeding tube

Culturelle
PlaceboDIETARY_SUPPLEMENT

one placebo 2x per day per feeding tube

Placebo

Eligibility Criteria

Age6 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • acute burn injury
  • consented within 10 days of injury
  • feeding tube present-

You may not qualify if:

  • GI disorder prior to burn
  • milk allergy or insensitivity
  • non-burned

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shriners Hospital for Children

Cincinnati, Ohio, 45229, United States

Location

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Nutrition Services

Study Record Dates

First Submitted

May 8, 2012

First Posted

May 25, 2012

Study Start

January 1, 2011

Primary Completion

January 1, 2013

Study Completion

December 1, 2015

Last Updated

November 13, 2013

Record last verified: 2013-11

Locations

US(1)