Treatment of C. Difficile Infection With Fecal Microbiota Transplantation (FMT)
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/30/2013 |
| Start Date: | August 2013 |
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.
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
We found this trial at
1
site
9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
(414) 266-2000
Children's Hospital of Wisconsin Nothing matters more than our children. At Children's Hospital of Wisconsin,...
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