Fecal Microbiota Transplantation as a Treatment for Ulcerative Colitis

Study Overview
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Brief Summary
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Ulcerative colitis (UC) is characterized by a disrupted homeostasis of the commensal bacterial population (dysbiosis). A promising therapy for restoration of the altered balance of the enteric microbiota is fecal microbial transplantation (FMT). FMT will ameliorate colitis via alterations of patients' microbiota and their proteolytic-dependent effect on epithelial permeability. Design: 80 patients will undergo 1:1 randomization for multiple FMT (Fecal Microbiota Transplantation) from a healthy donor or autologous (placebo) through colonoscopy and rectal enemas. The treating physicians and the patients will be blinded for the treatment arm. At the FMT visit (first week), blood and stool samples will be taken and patients will be filling out questionnaires to assess disease activity level. Every 2 weeks patients will come to a clinic for a follow up visit. 8 weeks after FMT, patients will undergo sigmoidoscopy to assess disease severity, biopsies will be taken as well.

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Procedure: Colonoscopy
* Procedure: Gastroscopy
* Drug: Fecal Microbiota
* Procedure: Enema


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over 3 month diagnosis of ulcerative colitis Active Colitis disease with endoscopic score >0 Ability to sign an informed consent Exclusion Criteria: Acute neutrophilia (under 500 neutrophils) Clostridium difficile infection Exposure to antibiotics 2 weeks prior to enrollment. Severe immune deficiency Hospitalization Proctitis involving less than 10cm of the rectum Malignancy with the past 5 years (excluding BCC) An unstable dose of steroids or 5ASA (5- aminosalicylic acid) with the past 2 weeks or of immunomodulators or biologic therapy within the past 12 weeks

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FMT from a healthy donor<br>Patients will undergo FMT 4 times during the study: first time, through a colonoscopy (sample volume: 250ml), and 3 more times (each sample volume: 100ml) during the following three days through: A Naso-jejunal feeding tube (that will be inserted through a gastroscopy) for patients suffering from colitis that involves more than 40 cm of the colon. Enemas, for patients suffering from colitis that involves the left colon up to 40 cm from the rectum. | Procedure: Colonoscopy<br>* Fecal microbiota transplantation through colonoscopy<br>Procedure: Gastroscopy<br>* Fecal microbiota transplantation through gastroscopy<br>Drug: Fecal Microbiota<br> <br> Procedure: Enema<br>* Fecal microbiota transplantation through enema<br>|
| Placebo Comparator: FMT from a self donated stool sample<br>Patients will undergo FMT 4 times during the study: first time, through a colonoscopy (sample volume: 250ml), and 3 more times (each sample volume: 100ml) during the following three days through: A Naso-jejunal feeding tube (that will be inserted through a gastroscopy) for patients suffering from colitis that involves more than 40 cm of the colon. Enemas, for patients suffering from colitis that involves the left colon up to 40 cm from the rectum. | Procedure: Colonoscopy<br>* Fecal microbiota transplantation through colonoscopy<br>Procedure: Gastroscopy<br>* Fecal microbiota transplantation through gastroscopy<br>Drug: Fecal Microbiota<br> <br> Procedure: Enema<br>* Fecal microbiota transplantation through enema<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical improvement | A composite measure- Will be measured by SCCAI (Simple Clinical Colitis Activity Index) and by MAYO SCORE | 8 weeks after FMT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histological remission assessed by sigmoidoscopy | Will be assessed by sigmoidoscopy | 8 weeks after FMT | 
| Long term remission assessed through questionnaires | Will be assessed through questionnaires | one year after FMT | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microbiota, Ulcerative Colitis