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)

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.

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 RCDI
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 4C 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