Treatment of C. Difficile Infection With Fecal Microbiota... | NCT01842347

Studies
Treatment of C. Difficile Infection With Fecal Microbiota Transplantation (FMT)

NCT01842347

Sponsor

Medical College of Wisconsin

Status

Withdrawn

Last Update Posted

Dec 13, 2013Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Clostridium Difficile Infection

Interventions

Fecal microbiota

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

Dec 2013

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2013

Primary Completion Date

Aug 2016Estimated

Completion Date

Not provided

First Submitted Date

Apr 25, 2013

First Submission Date that Met QC Criteria

Apr 26, 2013

First Posted Date

Apr 29, 2013Estimated

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

Dec 12, 2013

Last Update Posted Date

Dec 13, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to treat children with severe, moderate, resistant or relapsing C. difficile infection and to determine the changes in the intestinal microbiome (all of the bacteria living in the intestines) in children receiving FMT for C. difficile infection. Data will be collected throughout the FMT procedure to determine effectiveness and to help standardize this procedure. Stool samples will be collected to look at the different bacteria that are in the intestines before and after FMT.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pediatrics, C. Diff.	Experimental	Fecal Microbiota Transplantation in children with c. difficile infection	Other: Fecal microbiota

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fecal microbiota	Other		Pediatrics, C. Diff.

Measure	Description	Time Frame
Treatment of C. Difficile Infection with Fecal Microbiota Transplantation (FMT)		3 years

Eligibility Module

Eligibility Criteria

Recipient Inclusion Criteria

Older than 18 months of age
FMT procedure has been decided by the treating gastroenterologist and was based on:
1. Recurrent or relapsing CDI and:
  - Failure of standard medical therapy with metronidazole, vancomycin and fidaxomicin (over age 18 years. Fidaxomicin is not approved for <18years and insurance authorization may not be possible).
  - At least 2 episodes of CDI requiring hospitalization
2. Moderate CDI not responding to vancomycin for at least a week.
3. Severe CDI with no response to vancomycin after 4 hours.
English speaking

Recipient Exclusion Criteria

Lack of informed consent/assent.
Not eligible for FMT procedure

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Months

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Steven Werlin, MD	Medical College of Wisconsin	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital of Wisconsin		Milwaukee	Wisconsin	53226	United States

Condition Browse Module

MeSH Terms

ID	Term
D003015	Clostridium Infections

Ancestor Terms

ID	Term
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D001691	Biological Therapy
D013812	Therapeutics