Safety of FMT: OpenBiome Outcomes and Longitudinal Follow-up (STOOL) for Recurrent Clostridium Difficile Infection

Exclusion Criteria

• •Unable to comply with study follow-up procedures at discretion of MD
• •Unable to provide informed consent at discretion of MD
• •Participating in another clinical trial
• •Pregnant or nursing currently or planned pregnancy in next 1 year
• •Evidence of toxic megacolon or gastrointestinal perforation
• •Peripheral white blood cell count \>30 x 10\^9/L and/or temperature \>38 degrees Celsius
• •Admission to an intensive care unit within prior 7 days for any reason
• •Previously undergone FMT
• •Severely immunocompromised patients
• •* HIV infection (any CD4 count)
• •* AIDS-defining diagnoses
• •* Inherited/primary immune disorder
• •* Immunosuppressant medications:
• •Current or recent (\<3 months) treatment with anti-neoplastic agents
• •Current or recent (\<3 months) treatment with calcineurin inhibitors (tacrolimus, cyclosporine)
• •Current or recent (\<3 months) treatment with mycophenolate mofetil
• •Current or recent (\<3 months) treatment with monoclonal antibodies to B and T-Cells, anti-TNF, glucocorticoids, antimetabolites (azathioprine, 6-mercaptopurine)
• •Neutropenia with absolute neutrophil count (ANC) \<0.5 x 10\^9/L
• •Active gastroenteritis due to infectious cause other than CDI
• •Short gut syndrome
• •Colostomy
• •Ascites
• •End-stage liver disease
• •Untreated, in-situ colorectal cancer
• •Irritable bowel syndrome
• •Inflammatory bowel disease including Crohn's disease and ulcerative colitis
• •Microscopic colitis including collagenous colitis and lymphocytic colitis
• •Severe food allergy (anaphylaxis) that cannot be confirmed as having been excluded from a donor's diet within the five days prior to donation
• •Anorectal disorder/severe rectal sphincter tone abnormality or inability to retain enema material
• •Unable or unwilling to tolerate colonoscopy/sigmoidoscopy, colonoscopy prep, or enema for any reason at discretion of MD
• •Severe underlying disease that the patient is not expected to survive for the subsequent 12 months at the discretion of the MD.
• •Any conditions for which, in opinion of MD, the treatment may pose a health risk