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)

Phase 2

Terminated

Interventions: Biological: Low fecal microbiota dose
Biological: Mid fecal microbiota dose
Biological: High fecal microbiota dose

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Low fecal microbiota dose	Low fecal microbiota dose	receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days
Mid fecal microbiota dose	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
High fecal microbiota dose	High fecal microbiota dose	receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days

Primary Outcome Measures

Name	Time	Method
Safety as Assessed by Number of Participants With Diarrhea	180 days
Safety as Assessed by Number of Participants With Nausea	180 days
Safety as Assessed by Number of Participants With Bloating	180 days
Safety as Assessed by Number of Participants With Constipation	180 days
Safety as Assessed by Number of Participants With Vomiting	180 days