Clinical Response and Safety Following FMT for UC

Study Overview
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Brief Summary
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The study aims to evaluate the clinical efficacy and safety of fecal microbiota transplantation by automatic methods in the treatment of moderate to severe active ulcerative colitis. There are two groups according to FMT pathway ( through a naso-jejunal tube or transendoscopic enteral tubing). Patients were followed up until 2 weeks after the final FMT in hospital.

Official Title
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Clinical Response and Safety Following Fecal Microbiota Transplantation by Automatic Methods in Patients With Moderate-Severe Active Ulcerative Colitis

Conditions
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Inflammatory Bowel Diseases, Fecal Microbiota Transplantation

Intervention / Treatment
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* Other: FMT through a naso-jejunal tube
* Other: FMT through TET


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Eligible patients required a diagnosis of ulcerative colitis made by a primary gastroenterologist based upon history, physical exam, laboratory/radiological studies and gastrointestinal histology. All patients were age ≥ 18 year old at the time of enrollment. They had moderate to severe symptoms with a mayo score between 6 12 and an endoscopic subscore ≥2. Patient medication for UC could not have changed for at least one month prior to FMT. Exclusion Criteria: - Active or history of intraabdominal abscess, acute abdomen or other clinical emergencies requiring emergent management, pregnancy, prior history of FMT, prior history of TNF inhibitors use, or other serious systemic disease.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FMT through a naso-jejunal tube<br>The purified fecal microbiota was delivered into the intestine through a naso-jejunal tube. | Other: FMT through a naso-jejunal tube<br>* Prepared feces by automatic methods, then the purified fecal microbiota was delivered into the intestine through a naso-jejunal tube.<br>|
| Active Comparator: FMT through TET<br>The purified fecal microbiota was delivered into the intestine through a transendoscopic enteral tubing (TET) which is fixed to the cecum with clips under endoscopic guidance. | Other: FMT through TET<br>* Prepared feces by automatic methods, then the purified fecal microbiota was delivered into the intestine through a transendoscopic enteral tubing (TET) which is fixed to the cecum with clips under endoscopic guidance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical response | reduction in the Mayo score of ≥3 points and ≥30% from baseline, with a decrease in the rectal bleeding subscore of ≥1 point or a subscore of ≤1 | 2 weeks after FMT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical remission, safety and progression of disease | clinical remission: Mayo score ≤ 2, with no subscore > 1; progression of disease: measured by initiation of anti-TNFα or colectomy. Adverse event severity and relatedness was graded using NIH criteria. | 2 weeks after FMT |