Placebo Controlled Study of Fecal Microbiota Transplant (FMT) for a First or Second Episode of C. Difficile Infection in Adults Using a Frozen Encapsulated Inoculum

Exclusion Criteria

• •Delayed gastric emptying syndrome
• •Known chronic aspiration
• •Swallowing dysfunction or oral-motor dyscoordination, or inability or unwillingness to swallow multiple large capsules
• •Pregnant women; we have previously and will continue to include postpartum and breastfeeding women. Women of child bearing potential have a urine or serum human chorionic gonadotropin test at enrollment.
• •Patients with an acute illness unrelated to CDI or an acute exacerbation of underlying co-morbid condition
• •Neutropenia (ANC \<500) currently or expected within 2 weeks of FMT. (must have count within 7 d in relevant subjects, i.e. those with recent chemotherapy)
• •Subjects on high dose steroids (\>40 mg daily)
• •Subjects on multiple/combination immunosuppressive regimens including high dose corticosteroids, calcineurin inhibitors, lymphocyte depleting biologic agents, anti-tumor necrosis factor agents. Subjects on a stable dose of a SINGLE immunosuppressive agent like steroids, rituximab, infliximab, other anti-TNF agents, with approval of the treating physician may be enrolled. These subjects may be at greatest risk of complications and hospitalization if another relapse of CDI occurs and may benefit.
• •Patients with decompensated cirrhosis, advanced HIV/AIDS, recent bone marrow transplant, other cause of severe immunodeficiency.
• •Patients with a history of significant allergy to foods not excluded from the donor diet (excluded foods are tree nuts, peanuts, shellfish, eggs)
• •Ongoing systemic antibiotics for other infections (these people are better maintained on suppressive vancomycin and transplanted later). Subjects may have recently completed a course of antibiotics for another indication.
• •Advanced HIV/AIDS with cluster of differentiation 4 cells (CD4) count less than 50.
• •Allergy to chocolate/cocoa or gelatin, or unwillingness to ingest gelatin (in placebo capsules).