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)
Stopped early · Phase 2
Conditions studied: Recurrent C. Difficile Infection
In brief
To establish optimal dosing of lyophilized Fecal microbiota transplantation (FMT) product in the treatment of recurrent C. difficile infection
Key facts
- Study ID
- NCT03298048
- Run by
- The University of Texas Health Science Center, Houston
- People needed
- 17
- Starts
- 2017-12-21
- Expected to finish
- 2019-06-30
- Last updated by the study team
- 2020-03-06
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- The University of Texas Health Science Center at Houston — Houston, Texas, United States
Full record on ClinicalTrials.gov
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