Fecal Microbiota Transplantation for Ulcerative Colitis Through Colonic Transendoscopic Enteral Tubing

Study Overview
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Brief Summary
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To indicate the efficacy of Fecal microbiota transplantation (FMT) for the treatment of Ulcerative colitis (UC), The investigators design a multicenter, randomized controlled trial to perform FMT through colonic transendoscopic enteral tubing (TET) way, and evaluate the efficacy and safety of FMT for patients with moderate or severe UC.

Detailed Description
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Patients with moderate to severe UC will be screened (Mayo>6）. Participants will be divided into control and study groups by double blind. Control group and study group will receive a colonic endoscopy evaluation. And a TET tube will be fixed at ileocecum. Enema with 5-ASA 4g/day for 7days by TET will be performed as basic therapy for both control and study group. Study and control group will be given with fecal microbiota suspension and equal volume of saline by TET for three times every other day in one week. The follow-up will be performed at 1 week, 4 weeks and 12 weeks after first treatment. All the participants will receive a endoscopy evaluation at 12 weeks. Clinical remission, clinical improvement and safety are the primary endpoint at 12 weeks; Intestinal microbiota changing is recognized as the secondary endpoint.

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Drug: fecal microbiota transplantation
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Active, moderate to severe severity (Mayo score more than 6) Safety using history of 5-ASA. Able to undergo endoscopy examination. Exclusion Criteria: Immunosuppressive drugs and glucocorticoids using in 4 weeks Antibiotic using in 7 days High risk of toxic megacolon Colon cancer or neoplasia in pathophysiology Other severe diseases (eg: cardiovascular, respiratory, gastroenteral and kidney diseases)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control<br>5-ASA 4g/day enema through TET for 1 week; 200ml saline infusion through TET for 3 times every other day in one week | Drug: Saline<br> <br> |
| Experimental: Study group<br>5-ASA 4g/day enema through TET for 1 week; 200ml fecal microbiota suspension infusion through TET for 3 times every other day in one week | Drug: fecal microbiota transplantation<br>* Fecal microbiota which was purified from fresh stool defecated by a healthy donor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical remission | Total Mayo score less than 2 and no signal item more than 1 | 12 weeks | 
| Clinical improvement | Total Mayo score decreased more than 3 or decreased more than 30% | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intestinal microbiota changing | The change of intestinal microbiota composition after FMT compared with subject original microbiota and donor's microbiota | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fecal microbiota transplantation, Ulcerative colitis