To Evaluate the Feasibility, Safety, and Efficacy of TET for FMT Via Colonic Approach

Study Overview
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Brief Summary
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No technique by placing a tube through anus into cecum for whole colon administration. This study aimed to evaluate the feasibility, safety, and efficacy of transendoscopic enteral tubing (TET) in fecal microbiota transplantation (FMT) through whole colon.

Detailed Description
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The previous reported fecal microbiota transplantation (FMT)through whole colon. delivering ways were involved with upper digestive tract, middle digestive tract and lower digestive tract. FMT via colonoscope is the most common approach, participants have to endure the discomfortable of bowel preparation and colonoscopy, and FMT by colonoscopy was recommended for repeat FMT treatment in short period. Traditional enema infuses bacteria solution into rectal and sigmoid colon but cannot spread to whole colon.No technique by placing a tube through anus into cecum for whole colon administration, which could be maintained for repeat FMTs.To solve these problems, investigators designed a new technique called transendoscopic enteral tubing (TET).the TET tube was fixed at cecum by clips under endoscopy. This study aimed to evaluate the feasibility, safety, and efficacy of TET for FMT via colonic approach.

Official Title
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Feasibility, Safety, and Efficacy of Transendoscopic Enteral Tubing in Fecal Microbiota Transplantation

Conditions
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Inflammatory Bowel Diseases

Intervention / Treatment
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* Device: transendoscopic enteral tubing
* Device: colonoscope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mild to moderate ulcerative colitis (Montreal classification) Exclusion Criteria: Diagnosed as ulcerative colitis first time. No history of using Biologic, immunomodulatory therapy or corticosteroid therapy. With contraindication of endoscopy.

Ages Eligible for Study
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Minimum Age: 10 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| colonoscope via of FMT<br>FMT pathway is colonoscope | Device: colonoscope<br>* FMT via colonoscope is the most common approach.<br>|
| Transendoscopic enteral tubing<br>FMT was performed via TET tube | Device: transendoscopic enteral tubing<br>* Investigators designed transendoscopic enteral tubing (TET).The enteral segment of the tube is fixed in the ileocecum with distal segment fixed buttocks. The tube was used for FMT and colonic local administration<br>* Other names: TET;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| durability of clinical remission | The durability of clinical remission (days) after Fecal Microbiota Transplantation procedure by TET.Defined as Montreal score S0 (clinical remission) | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients with worsened disease | Number of patients with worsened disease. Increase in Montreal score S1, S2 and S3. | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammatory Bowel Diseases, Fecal Microbiota Transplantation, transendoscopic enteral tubing