NCT02318992 - Fresh, Frozen or Lyophilized Fecal Microbiota Transplantation for Multiple Recurrent C. Difficile Associated Diarrhea

Inclusion Criteria: Recipients - Male and female patients ≥ 18 years of age - Sexually active male and female patients of child-bearing potential must agree to use an effective method of birth control during the treatment and follow-up period - Female patients of child-bearing potential must have a negative pregnancy test in the 72 hours before the procedure - Required to sign an informed consent form - Deemed likely to survive for ≥ 3 months after enrolment - Diagnosis of ≥ 3 recurrent CDAD (RCDAD) bouts in outpatients or ≥ 2 bouts of CDAD in an inpatient without other explanation for diarrhea and with ≥ 2 positive fecal tests for C. difficile toxin - Referred by subjects attending physician who will provide non-transplant care for the subject and follow up at 1, 7, 14, 30 days after FMT - Received at least one course of adequate antibiotic therapy for CDAD (≥ 10 days of vancomycin at a dose of ≥125 mg four times per day, ≥ 10 days of metronidazole at a dose of 500mg three times per day or fidaxomixin 200mg twice a day for 10 days - Anti-Clostridium difficile infection (CDI) antibiotic treatment stopped 2-4 days before the transplantation Donors - Able to provide and sign informed consent - Able to complete and sign the donor questionnaire - Able to adhere to fecal transplantation stool collection requirements Exclusion Criteria: Recipients - Patients with neutropenia with absolute neutrophil count <0.5 x 109/L - Evidence of toxic megacolon or gastrointestinal perforation on abdominal x-ray - Peripheral white blood cell count > 15.0 x 109/L AND temperature > 38.0 °C - Active gastroenteritis due to Salmonella, Shigella, E. coli 0157:H7, Yersinia or Campylobacter, and Norovirus - Presence of colostomy - Unable to tolerate human biotherapy (HBT) for any reason - Requiring systemic antibiotic therapy for more than 7 days - Actively taking Saccharomyces boulardii or other probiotic - 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 - Prolonged compromised immunity due to cytotoxic chemotherapy or HIV infection Donors - Test positive for any of variables - History of any type of active cancer or autoimmune disease - History of risk factors for acquisition of HIV, syphilis, Hepatitis B, Hepatitis C, prion or any neurological disease as determined by the donor questionnaire - History of gastrointestinal disorder, e.g., inflammatory bowel disease, irritable bowel syndrome, chronic constipation or diarrhea - Antibiotic use or any systemic immunosuppressive agents in the 3 months prior to stool donation - Receipt of any type of live vaccine within 3 months prior to stool donation - Current or previous medical or psychosocial condition - Body mass index over 30