Status:
WITHDRAWN
Randomized Clinical Trial of Standard FMT Treatments
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
Clostridium Difficile
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a single center, randomized, parallel assignment, double-blinded, efficacy and safety study to be conducted in subjects with recurrent C. difficile Infection (RCDI). Approximately 200 subjects...
Detailed Description
The endpoints of the study are to evaluate the efficacy and safety of lyophilized product by capsules obtained either from single or three donors and the prevention of subsequent bouts of CDI in 60 da...
Eligibility Criteria
Inclusion
- Male and female subjects 18 years of age or older.
- Sexually active male and female subjects of childbearing potential agree to use an effective method of birth control during the study.
- Female subjects of childbearing potential will be asked if they could be pregnant. If the subject is unsure a pregnancy test will be completed
- Subject/LAR willing and able to provide informed consent.
- Able to follow study procedures and complete the follow-up questionnaire for safety.
- Subject must have an attending physician who will provide non-transplant care (Either PI of this study or referring physician).
- Medical history of ≥ 3 bouts of CDI in outpatient or ≥ 2 bouts of CDI in inpatient with either group having ≥ 2 positive fecal tests for C. difficile toxin and at least one bout of CDI within 6 months of enrollment.
- Received at least two courses of standard-of-care antibiotic therapy for CDI.
Exclusion
- Unable to take capsules orally.
- Requiring systemic non-C. difficile antibiotic therapy within 14 days prior to FMT.
- Unwilling to stop taking non-dietary probiotics 24-96 hours prior to FMT.
- Unable to stop taking bile acid sequestrants (e.g. cholestyramine) 24-96 hours prior to FMT.
- Unable to stop use of drugs with CDI activity: oral vancomycin, oral or IV metronidazole, fidaxomicin, rifaximin or nitazoxanide 24-96 hours prior to FMT and after FMT.
- Receipt of CDI monoclonal antibodies as treatment for the most recent bout of CDI.
- Life expectancy of \< 6 months.
- In the opinion of investigator, subject for any reason, should be excluded from the study.
Key Trial Info
Start Date :
January 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04729790
Start Date
January 10 2020
End Date
April 30 2022
Last Update
January 29 2021
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