- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01842347
Treatment of C. Difficile Infection With Fecal Microbiota Transplantation (FMT)
December 12, 2013 updated by: Steve Werlin, Medical College of Wisconsin
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Wisconsin
-
Milwaukee, Wisconsin, United States, 53226
- Children's Hospital of Wisconsin
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pediatrics, C. Diff.
Fecal Microbiota Transplantation in children with c. difficile infection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Treatment of C. Difficile Infection with Fecal Microbiota Transplantation (FMT)
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Steven Werlin, MD, Medical College of Wisconsin
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2013
Primary Completion (Anticipated)
August 1, 2016
Study Registration Dates
First Submitted
April 25, 2013
First Submitted That Met QC Criteria
April 26, 2013
First Posted (Estimate)
April 29, 2013
Study Record Updates
Last Update Posted (Estimate)
December 13, 2013
Last Update Submitted That Met QC Criteria
December 12, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FMT
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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