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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-10-31

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.

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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.

Conditions

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Inflammatory Bowel Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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colonoscope via of FMT

FMT pathway is colonoscope

colonoscope

Intervention Type DEVICE

FMT via colonoscope is the most common approach.

Transendoscopic enteral tubing

FMT was performed via TET tube

transendoscopic enteral tubing

Intervention Type DEVICE

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

Interventions

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transendoscopic enteral tubing

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

Intervention Type DEVICE

colonoscope

FMT via colonoscope is the most common approach.

Intervention Type DEVICE

Other Intervention Names

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TET

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.

Minimum Eligible Age

10 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No