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

• Status: Completed
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

Summary

In this study the investigators will evaluate patients with IBD and and at least 2 confirmed c.difficile infections who will be undergoing FMT. The investigators will assess patients before FMT and then follow patients prospectively post FMT at week 1, 8 and 12 to assess for recurrence of c.difficile infection and IBD outcomes.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Collaborators: Icahn School of Medicine at Mount Sinai; Indiana University; The Miriam Hospital

Criteria

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