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