Fecal Microbiota Transplantation for C. Difficile Infection in Solid Organ Transplant Recipients

This is an interventional treatment trial for Clostridium Difficile Infection Recurrence Read More

Inclusion Criteria:

• Is willing to provide written informed consent.
• Is willing to comply with all study procedures and be available for the duration of the study.
• Can take oral medication
• At least 18 years of age.
• Is a solid organ transplant (SOT) recipient
• Has had at recurrent C. difficile infection defined as: positive C. difficile testing in stool and diarrhea (three or more loose stools over 24 hours) during the 180 day period following completion of treatment for prior episode
• History of positive IgG test to cytomegalovirus (CMV) and Epstein-Barr Virus (EBV) for subject or donor
• Clinical response to 4-14 days of oral antibiotic standard of care treatment for the current episode of CDI. Clinical response is defined as greater than or equal to 25% reduction of diarrhea.
• Negative urine or serum pregnancy test for women of childbearing potential and agree to use effective form of contraception until 6 weeks post treatment

Exclusion Criteria:

• Major bowel resection surgery within 90 days of randomization
• Active intestinal disease (e.g. Crohn's disease, ulcerative colitis)
• History of total colectomy or bariatric surgery
• Known or suspected toxic megacolon and/or small bowel ileus
• Presence of colostomy or ileostomy.
• Taking concomitant antibiotics within 48 hours of Visit 2. Topical antibiotics, and antibiotics for transplant prophylaxis are permitted
• Dysphagia; oropharyngeal, S), or patient has evidence of dysphagia when the 'safety test' capsule is administered
• Currently receiving medication for treatment of acute rejection and/or develop acute rejection prior to administration of FMT
• Active, Severe Gastroparesis
• Unwilling to withhold probiotics. Probiotics include supplements, prescriptions, and non-prescriptions. Foods (like yogurt) are not prohibited
• Neutropenia, ≤ 500 neutrophils/ml [noted in medical records and resulted within 7 days of Visit 1])
• Symptomatic co-infection with another intestinal pathogen as determined by chart review
• Concurrent intensive induction chemotherapy, radiation therapy or biological treatment for any active malignancy. Patients on maintenance chemotherapy could be enrolled after consultation with the study Medical Monitor
• Any severe food allergy, defined as a history of anaphylaxis, systemic urticarial or angioedema attributed to a food and requiring current avoidance precautions
• Expected life expectancy is less than 6 months
• Use of investigational drugs, biologics, or devices within 30 days prior to randomization.
• Women who are pregnant, lactating or planning on becoming pregnant during the study
• Not suitable for study participation due to other reasons at the discretion of the investigators