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)

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