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

• Conditions: Inflammatory Bowel Diseases
• Interventions: Device: transendoscopic enteral tubing; Device: colonoscope

• Registration Number: NCT02560727
• Lead Sponsor: The Second Hospital of Nanjing Medical University

Brief Summary

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

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 Timeline

• Study Start: 2014-10
• Status Verified: 2015-09
• Primary Completion: 2015-09
• Study First Submitted: 2015-09-21
• Study First Submitted QC: 2015-09-24
• Last Update Submitted: 2015-09-24
• Study First Posted: 2015-09-25
• Last Update Posted: 2015-09-25
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Transendoscopic enteral tubing	transendoscopic enteral tubing	FMT was performed via TET tube
colonoscope via of FMT	colonoscope	FMT pathway is colonoscope

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Patients with worsened disease	one year	Number of patients with worsened disease. Increase in Montreal score S1, S2 and S3.

Trial Locations

Locations (1)

Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China