Status:
WITHDRAWN
Treatment of C. Difficile Infection With Fecal Microbiota Transplantation (FMT)
Lead Sponsor:
Medical College of Wisconsin
Conditions:
Clostridium Difficile Infection
Eligibility:
All Genders
18+ years
Phase:
NA
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 livin...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01842347
Start Date
August 1 2013
Last Update
December 13 2013
Active Locations (1)
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1
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226