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

Primary Purpose

Clostridium Difficile Infection

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fecal microbiota
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clostridium Difficile Infection

Eligibility Criteria

18 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Recipient Inclusion Criteria

  1. Older than 18 months of age

  2. 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.
  3. English speaking

Recipient Exclusion Criteria

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

Sites / Locations

  • Children's Hospital of Wisconsin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pediatrics, C. Diff.

Arm Description

Fecal Microbiota Transplantation in children with c. difficile infection

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 25, 2013
Last Updated
December 12, 2013
Sponsor
Medical College of Wisconsin
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1. Study Identification

Unique Protocol Identification Number
NCT01842347
Brief Title
Treatment of C. Difficile Infection With Fecal Microbiota Transplantation (FMT)
Official Title
Treatment of C. Difficile Infection With Fecal Microbiota Transplantation (FMT)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Withdrawn
Study Start Date
August 2013 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Difficile Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pediatrics, C. Diff.
Arm Type
Experimental
Arm Description
Fecal Microbiota Transplantation in children with c. difficile infection
Intervention Type
Other
Intervention Name(s)
Fecal microbiota
Primary Outcome Measure Information:
Title
Treatment of C. Difficile Infection with Fecal Microbiota Transplantation (FMT)
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Recipient Inclusion Criteria Older than 18 months of age FMT procedure has been decided by the treating gastroenterologist and was based on: 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 Moderate CDI not responding to vancomycin for at least a week. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Werlin, MD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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