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

Mass General Brigham

Status and phase

Completed

Phase 2

Phase 1

Conditions

Inflammatory Bowel Diseases

Clostridium Difficile Infection

Treatments

Drug: Fecal Microbiota Transplantation

Study type

Interventional

Funder types

Other

Identifiers

NCT03106844

2017P000386

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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