Status:
RECRUITING
Fecal Microbiota Transplantation for C Diff Infection
Lead Sponsor:
Englewood Hospital and Medical Center
Conditions:
Clostridium Difficile Infection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of this study is to provide treatment with Fecal Microbiota Transplantation (FMT) to patients with recurrent or refractory Clostridium difficile infection (CDI). It has been shown that g...
Eligibility Criteria
Inclusion
- Subject is at least 18 years old.
- Subject has recurrent or relapsing CDI defined as:
- At least three episodes of mild-to-moderate CDI and failure of a 6-8 week taper with vancomycin with or without an alternative antibiotic (e.g., rifaximin, nitazoxanide, fidaxomicin). OR
- At least two episodes of severe CDI resulting in hospitalization and associated with significant morbidity. OR
- Moderate CDI not responding to standard therapy (vancomycin) for at least a week. OR
- Severe C. difficile infection with toxic megacolon, not responding to standard therapy or the use of IVIg.
- Subject is willing and able to provide informed consent.
- If a female of childbearing potential, subject has agreed to use an acceptable form of birth control for up to 4 weeks after FMT treatment.
Exclusion
- Subject is pregnant.
- Subject is unable to comply with study requirements.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01905709
Start Date
July 1 2013
End Date
December 1 2026
Last Update
April 13 2025
Active Locations (1)
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1
Englewood Hospital and Medical Center
Englewood, New Jersey, United States, 07631