Faecal Microbiota Transplantation in Ulcerative Colitis

Study Overview
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Brief Summary
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The purpose of this study is to determine whether fecal microbiota transplantation (FMT) is safe and efficacious in the treatment of chronic active ulcerative colitis (UC) by conducting a randomised controlled trial

Detailed Description
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This study involves the assessment of the safety and efficacy of FMT in the treatment and induction of remission for patients with mild to moderate ulcerative colitis. It is a double blind study with patients randomised in a 1:1 manner to either active or placebo therapy

Official Title
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Faecal Microbiota Transplantation for Chronic Active Ulcerative Colitis - A Randomised Double Blind Controlled Study of Efficacy & Safety

Conditions
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Ulcerative Colitis, Inflammatory Bowel Disease

Intervention / Treatment
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* Biological: FMT infusions
* Other: Placebo infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ulcerative colitis >3 months duration Active mild-moderate ulcerative colitis (Mayo 4-10) Ulcerative colitis of any extent except isolated proctitis < 5cm Live within driving distance of clinical site (to attend multiple study visits) Exclusion Criteria: Pregnancy Active gastrointestinal infection Other gastrointestinal disease / comorbidities Prior colonic surgery Recent antibiotic or probiotic use Prednisone > 20mg Monoclonal antibody immunosuppressive therapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FMT infusions<br>FMT infusions constituted from stool provided by healthy, screened donors | Biological: FMT infusions<br>* Active FMT derived from healthy anonymous pre-screened donors<br>|
| Placebo Comparator: Placebo arm<br>Placebo infusions | Other: Placebo infusion<br>* Placebo infusion not containing any donor microbial material<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Clinical remission & Endoscopic remission / response as measured by Mayo subscores |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical remission as measured by Mayo subscores |  | 8 weeks | 
| Clinical response as measured by Mayo subscores |  | 8 weeks | 
| Endoscopic healing as measured by UCEIS |  | 8 weeks | 
| Treatment failure rate as defined by Mayo subscores |  | 8 weeks | 
| Quality of life as measured by IBDQ |  | 8 weeks | 
| Safety and tolerability as measured by adverse event data |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ulcerative Colitis, Inflammatory Bowel Disease, Fecal Transplantation, Fecal Microbiota Transplantation