ICON-2: FMT and Bezlotoxumab Compared to FMT and Placebo for Patients With IBD and CDI

Exclusion Criteria

• •Unable or unwilling to undergo a colonoscopy
• •Inpatient status, though patients can be screened while inpatients, the must be outpatient for the planned colonoscopy.
• •Anticipated immediate or upcoming surgery within 30 days
• •Need for continued non-anti-CDI antibiotic therapy
• •History of total proctocolectomy
• •Female patients who are pregnant or breastfeeding or plan to become pregnant in the next 6 months.
• •Patients who are unable to give informed consent
• •Participation in a clinical trial in the preceding 30 days or simultaneously during this trial
• •Severe food allergy (anaphylaxis or anaphylactoid-like reaction)
• •Life expectancy \< 6 months
• •Unable to adhere to protocol requirements
• •Patient who have received an FMT in the past year
• •Any condition that the physician investigators deems unsafe, including other conditions or medications that the investigator determines that it will put the subject at greater risk from FMT
• •Patient who is diagnosed with NYHA class 3 or 4 Heart Failure
• •Lab value of WBC \<3.0 x 103/mm3 , Platelets \<100 x 103/mm3 , ALT or AST \> 1.5 x institutional ULN
• •EBV or CMV negative if a patient is severely immunosuppressed ( defined as 3 or more immunosuppressing agents)