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

The Second Hospital of Nanjing Medical University200 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Inflammatory Bowel Diseases

Interventions

transendoscopic enteral tubingDEVICE

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

colonoscopeDEVICE

FMT via colonoscope is the most common approach.

Eligibility

Sex: ALLMin age: 10 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

RECRUITING

Outcomes

Primary Outcomes

durability of clinical remission

The durability of clinical remission (days) after Fecal Microbiota Transplantation procedure by TET.Defined as Montreal score S0 (clinical remission)

Time frame: One year

Secondary Outcomes

Patients with worsened disease

Number of patients with worsened disease. Increase in Montreal score S1, S2 and S3.

Time frame: one year

Central Contacts

Faming Zhang, MD,PhD

CONTACT

086-25-58509883 fzhang@njmu.edu.cn

Data from ClinicalTrials.gov

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