Phase II. 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)
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Safety as Assessed by Number of Participants With Diarrhea
Study Overview
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 study and randomized at 1:1:1 ratio to receive lyophilized donor intestinal bacteria with various doses in capsules. All subjects will be followed for approximately 180 days following FMT for safety.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
Low fecal microbiota dose
receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days
Intervention: Low fecal microbiota dose (Biological)
Mid fecal microbiota dose
receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment
Intervention: Mid fecal microbiota dose (Biological)
High fecal microbiota dose
receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days
Intervention: High fecal microbiota dose (Biological)
Outcomes
Primary Outcomes
Safety as Assessed by Number of Participants With Diarrhea
Time Frame: 180 days
Safety as Assessed by Number of Participants With Nausea
Time Frame: 180 days
Safety as Assessed by Number of Participants With Bloating
Time Frame: 180 days
Safety as Assessed by Number of Participants With Constipation
Time Frame: 180 days
Safety as Assessed by Number of Participants With Vomiting
Time Frame: 180 days
Secondary Outcomes
- Number of Participants With Recurrent C. Difficile Infection(6 months)
Investigators
Herbert DuPont
Professor of Medicine
The University of Texas Health Science Center, Houston