Fecal Microbiota Transplantation (FMT) in Clostridium Difficile Infection (CDI) Not Responding to Antibiotics

This is a prospective, descriptive cohort study. Patients will receive current standard of care.

Once a potential subject is planned for FMT, they will be approached by study coordinators or investigators for participation in the study. If they agree to participate in the study, then patient health, medical and demographic information will be collected from the patient and/or from the medical record and entered into the research database, and associated with a research code with which the stool samples will also be labeled.

The study coordinator will be responsible for ensuring completion of the study questionnaire, which consists of pre- and post-FMT sections. The questionnaire will be attempted to be administered in person by the physician or study coordinator at a clinic visit, but may on occasion be completed at home and mailed in to the study coordinator or physician, or completed over the phone with the study coordinator or physician.

Stool preparations will be obtained by a nonprofit third party, OpenBiome, with whom the University of North Carolina has collaborated for over one year. Preparations include a 250mL (milliliter) preparation for lower administration, a 30mL preparation for upper administration, and frozen capsules (30 in one treatment) for oral delivery.

The actual FMT procedure will be performed in the majority of cases by colonoscopy. Other possible routes of administration are via nasogastric or nasoduodenal tube (with upper formulation), enema and frozen oral tablets. The current preferred route of administration is via colonoscopy, based on observation (no head-to-head) trials showing improved efficacy, but standards of care may change in the future. In all cases, the route of administration will be based on patient characteristics and preferences, not for purposes related to the study. In all cases, informed consent for the treatment will be documented as guided by the Food and Drug Administration (FDA). The patient will stop all antibiotics (including vancomycin or other antibiotics against C. diff) at least 2 days prior to FMT. For all administrations other than oral capsules, patients will perform a bowel preparation with 4 liters of Golytely or equivalent osmotic laxative split between the evening prior to the procedure and the morning of the procedure. In a minority of instances, especially for pediatric patients, the patient may be electively admitted to the hospital the night before, to monitor medical stability during the preparation, facilitate bowel preparation, and provide intravenous hydration. The bowel cleansing preparation is generally taken orally, though in rare instances must be administered via nasogastric or nasoduodenal (NG/ND) tube. Hospital admission and bowel preparation via NG/ND tube will only be performed if indicated as standard-of-care, not for purposes specifically related to the study.