Status:
TERMINATED
Dose Ranging Study of the Safety and Efficacy of Orally Administered Lyophilized Fecal Microbiota Product (PRIM-DJ2727) for the Treatment of Recurrent Clostridium Difficile Infection (CDI)
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
Recurrent C. Difficile Infection
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
Brief Summary
To establish optimal dosing of lyophilized Fecal microbiota transplantation (FMT) product in the treatment of recurrent C. difficile infection
Detailed Description
This is a single center, randomized, parallel assignment, double-blinded, safety and efficacy study to be conducted in subjects with recurrent CDI. Approximately 300 subjects will be enrolled in the s...
Eligibility Criteria
Inclusion
- Sexually active female subjects of child-bearing potential must agree to use an effective method of birth control during the treatment and follow-up period
- Female subjects of child-bearing potential must have a negative pregnancy test on the day of the procedure.
- Subject willing to sign an informed consent form
- Subject deemed likely to survive for ≥ 1 year after enrollment
- Able to follow study procedure and follow-ups
- Subjects' attending physician will provide non-transplant care for the subject
- Diagnosed by medical history of ≥ 3 bouts of CDI in outpatients or ≥ 2 bouts of recurrent CDI in an inpatient with ≥ 2 positive fecal tests for C. difficile toxin
- Received at least one course of adequate antibiotic therapy for CDI (≥ 10 days of vancomycin or metronidazole or fidaxomicin) since last bout of CDI
- Have a 4 degrees Celsius refrigerator at home to keep the second dose FMT for overnight
Exclusion
- Unable to take capsules orally
- Requiring systemic non-C. difficile antibiotic therapy within 14 days prior to FMT
- Actively taking Saccharomyces boulardii or other probiotic at the time of FMT other than that found in fortified foods
- Need for continuing use of drugs with CDI activity: oral vancomycin, oral or IV metronidazole, fidaxomicin, rifaximin or nitazoxanide at the time of FMT and after FMT
- Severe underlying disease such that the patient is not expected to survive for one or more years or unstable medical condition requiring daily change in treatments
Key Trial Info
Start Date :
December 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2019
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03298048
Start Date
December 21 2017
End Date
June 30 2019
Last Update
March 6 2020
Active Locations (1)
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1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030