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

Nanjing Medical University

Status

Unknown

Conditions

Inflammatory Bowel Diseases

Treatments

Device: transendoscopic enteral tubing

Device: colonoscope

Study type

Observational

Funder types

Other

Identifiers

NCT02560727

TET-CN-121002

Details and patient eligibility

About

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.

Full description

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.

Enrollment

200 estimated patients

Sex

All

Ages

10 to 70 years old

Volunteers

No Healthy Volunteers

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.