Faecal Bacteriotherapy for Ulcerative Colitis

Study Overview
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Brief Summary
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The etiopathogenesis of ulcerative colitis (UC) is not fully understood. One of the theories of UC pathogenesis represents a pathological response of mucosal immunity to intestinal microbiota. Potential therapeutic procedure how to affect this fact is the faecal microbiota transplantation (FMT). Review of the literature on FMT suggests great potential as the treatment for UC, but two prospective controlled study that has been published yet are inconsistent. The first objective of the project is to compare the administration of FMT enema with mesalazine enema for inducing remission in patients with active left-sided UC in the form of a prospective, randomized, controlled study. The second objective is to observe changes in the intestinal microbiota during and after FMT focusing on bacterial DNA sequencing to identify the bacterial species which are responsible for the effect of the FMT.

Official Title
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Faecal Bacteriotherapy for Ulcerative Colitis

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Other: Faecal bacterial transplantation
* Drug: Mesalazine 4G Enema


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Left-sided ulcerative colitis > 15cm ongoing more than 3 month Mayo score < 10 Endoscopic Mayo score ≥ 2 Exclusion Criteria: Anti-TNF medication in the previous 6 months Cyclosporine in the previous 4 weeks Methotrexate in the previous 2 months Prednisone > 10mg The real risk of colectomy in the near future Positive stool culture (Salmonella, Shigella, Yersinia, Campylobacter, pathogenic E. coli) CMV infection Pregnancy, breastfeeding women

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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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
Interventional Model Description: Patients will be split into two branches of the study by randomization criteria (gender, imunosupresive therapy). Each branch of the study will have 25-30 patients. The first group will be treated with 4 g mesalazine enema 1x daily for 2 weeks, then every other day until the end of the 6th week. A second group of patients will be applied enema prepared from 50 g of stool of examined donor dissolved in 150 ml of normal saline, the 1st week 5 times, than one time a week until the end of the 6th week.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mesalazine enema<br>Will be treated with 4 g mesalazine enema 1x daily for 2 weeks, then every other day until the end of the 6th week. | Drug: Mesalazine 4G Enema<br>* Standard mesalazine enema<br>|
| Experimental: Faecal bacterial transplantation enema<br>Will be applied enema prepared from 50 g of stool of examined donor dissolved in 150 ml of normal saline, the 1st week 5 times, than one time a week until the end of the 6th week. | Other: Faecal bacterial transplantation<br>* Enema prepared from 50 g of stool of examined donor dissolved in 150 ml of normal saline<br>* Other names: FMT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical remission | Mayo score ≤ 2 with no subscore > 1 | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopic remission | Mayo endoscopic score = 0 | Week 6 and 12 | 
| Clinical response | Decrease of Mayo score ≥ 2 | Week 6 and 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Feacal bacterial transplantation, Left-sided ulcerative colitis