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

Completed · Phase 1/Phase 2

Conditions studied: Inflammatory Bowel Diseases, Clostridium Difficile Infection

In brief

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.

Key facts

Study ID

NCT03106844

Run by

Brigham and Women's Hospital

People needed

50

Starts

2017-08-01

Expected to finish

2020-12-31

Last updated by the study team

2021-02-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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