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

Study Overview
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Brief Summary
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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.

Official Title
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The ICON Study: Inflammatory Bowel Disease and Recurrent Clostridium Difficile Infection: Outcomes After Fecal Microbiota Transplantation

Conditions
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Inflammatory Bowel Diseases, Clostridium Difficile Infection

Intervention / Treatment
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* Drug: Fecal Microbiota Transplantation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>All patients in this study will receive Fecal Microbiota Tranplantation | Drug: Fecal Microbiota Transplantation<br>* Patients with at least 2 episodes of CDI and IBD will undergo a single FMT<br>* Other names: FMT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With FMT Failure | Recurrence of c.diffile infection | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants Colonized With C.Difficile | asymptomatic patients with positive stool testing for c.difficile via polymerase chain reaction testing | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FMT, IBD