The ICON Study: Outcomes After FMT for Patients With IBD and CDI

Exclusion Criteria

• •Unable or unwilling to undergo a colonoscopy
• •Inpatient status
• •Anticipated immediate or upcoming surgery within 30 days
• •Need for continued non-anti-CDI antibiotic therapy
• •History of total or subtotal proctocolectomy
• •Isolated ileal or small bowel disease
• •Pregnancy or lactation
• •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
• •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
• •Known concurrent HIV, Hepatitis B or C infection
• •Concurrent PSC
• •Patients with WBC\< 3.0 x109th/L at baseline
• •Patients with platelet count \< 100 x109th/L
• •Patients with initial elevation of AST or ALT \> 1.5 times above normal limit at baseline
• •Non - steroidal anti-inflammatory medications (NSAIDs) as long-term treatment, defined as use for at least 4 days a week each month
• •Treatment with vancomycin or metronidazole for more then 60 days prior to enrollment