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

• Fecal Microbiota Transplantation (Drug), also known as FMT: Patients with at least 2 episodes of CDI and IBD will undergo a single FMT

Primary outcomes

• Number of Participants With FMT Failure [8 weeks]: Recurrence of c.diffile infection

Secondary outcomes

• Participants Colonized With C.Difficile [8 weeks]: asymptomatic patients with positive stool testing for c.difficile via polymerase chain reaction testing

Sex: All, ages: 18 Years to any

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

Participant flow

Outcome results

• Number of Participants With FMT Failure (Primary), Count of participants, Participants: Treatment 4
• Participants Colonized With C.Difficile (Secondary), Count of participants, Participants: Treatment 5

Adverse events

Time frame: Adverse event data was collected through week 26 (6 months)

Serious adverse events by term

Other adverse events by term

• Study Protocol and Statistical Analysis Plan (PDF, 2019-07-07)

• Jessica R Allegretti, MD, MPH, Principal investigator, Brigham and Women's Hospital