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

Inclusion Criteria:

- Adults age 18 or greater

- Confirmed recurrent CDI by positive PCR or EIA toxin test defined at ≥ 2 episodes and
vancomycin failure within one year with the most recent being within the past 3
months.

- Confirmed diagnosis of IBD with colonic involvement (ulcerative colitis, Crohn's
colitis or ileocolitis or indeterminate colitis) for ≥ 3 months

- Undergoing FMT via colonoscopy for CDI as part of standard medical care

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