Clinical trial NCT03106844: The ICON Study: Outcomes After FMT for Patients With IBD and CDI
Official title: The ICON Study: Inflammatory Bowel Disease and Recurrent Clostridium Difficile Infection: Outcomes After Fecal Microbiota Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Inflammatory Bowel Diseases
Clostridium Difficile Infection
Keywords: FMT
IBD
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Indiana University
name: Icahn School of Medicine at Mount Sinai
name: The Miriam Hospital
First posted: 2017-04-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Number of Participants With FMT Failure
timeFrame: 8 weeks
Secondary outcomes:
measure: Participants Colonized With C.Difficile
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Jessica R Allegretti, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: