Study of Culturelle in the Prophylaxis of Infection and D... | NCT01605747

Studies
Study of Culturelle in the Prophylaxis of Infection and Diarrhea

NCT01605747

Sponsor

Shriners Hospitals for Children

Status

Terminated

Last Update Posted

Nov 13, 2013Estimated

Enrollment

20Actual

Phase

Phase 2

Conditions

Pediatric Burns

Interventions

Culturelle
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study was stopped due to inavailability of subjects meeting eligibility criteria.

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Jan 2013Actual

Completion Date

Dec 2015Estimated

First Submitted Date

May 8, 2012

First Submission Date that Met QC Criteria

May 23, 2012

First Posted Date

May 25, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 12, 2013

Last Update Posted Date

Nov 13, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Michele Gottschlich, Director, Nutrition Services, Shriners Hospitals for ChildrenPrincipal Investigator

Lead Sponsor

Shriners Hospitals for ChildrenOTHER

Collaborators

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Culturelle	Experimental		Dietary Supplement: Culturelle
Placebo	Placebo Comparator		Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Culturelle	Dietary Supplement	one capsule 2x per day per feeding tube	Culturelle

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shriners Hospital for Children		Cincinnati	Ohio	45229	United States