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

Inclusion criteria

• Adults age 18 or greater
• History of ≥ 2 episodes of recurrent CDI. CDI is defined as the presence of diarrhea ( Bristol 6 or 7 for 48 hours and a confirmatory test for CDI). Preferred testing will be a two-step method using GDH/EIA toxin, though PCR will be accepted based on hospital availability with confirmation of the most recent episode occurring within the prior 3 months
• Confirmed diagnosis of IBD (ulcerative colitis, Crohn's disease or indeterminate colitis)
• Undergoing FMT via colonoscopy for CDI as part of standard medical care

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)