Fecal Microbiota Transplantation for Ulcerative Colitis Through Colonic Transendoscopic Enteral Tubing

December 15, 2016 updated by: Faming Zhang, The Second Hospital of Nanjing Medical University
To indicate the efficacy of Fecal microbiota transplantation (FMT) for the treatment of Ulcerative colitis (UC), The investigators design a multicenter, randomized controlled trial to perform FMT through colonic transendoscopic enteral tubing (TET) way, and evaluate the efficacy and safety of FMT for patients with moderate or severe UC.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

  1. Patients with moderate to severe UC will be screened (Mayo>6）.
  2. Participants will be divided into control and study groups by double blind.
  3. Control group and study group will receive a colonic endoscopy evaluation. And a TET tube will be fixed at ileocecum.
  4. Enema with 5-ASA 4g/day for 7days by TET will be performed as basic therapy for both control and study group. Study and control group will be given with fecal microbiota suspension and equal volume of saline by TET for three times every other day in one week.
  5. The follow-up will be performed at 1 week, 4 weeks and 12 weeks after first treatment. All the participants will receive a endoscopy evaluation at 12 weeks. Clinical remission, clinical improvement and safety are the primary endpoint at 12 weeks; Intestinal microbiota changing is recognized as the secondary endpoint.

Study Type

Interventional

Enrollment (Anticipated)

188

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210011
        • Recruiting
        • Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Active, moderate to severe severity (Mayo score more than 6)
  • Safety using history of 5-ASA.
  • Able to undergo endoscopy examination.

Exclusion Criteria:

  • Immunosuppressive drugs and glucocorticoids using in 4 weeks
  • Antibiotic using in 7 days
  • High risk of toxic megacolon
  • Colon cancer or neoplasia in pathophysiology
  • Other severe diseases (eg: cardiovascular, respiratory, gastroenteral and kidney diseases)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: control
5-ASA 4g/day enema through TET for 1 week; 200ml saline infusion through TET for 3 times every other day in one week
Drug: Saline
Experimental: Study group
5-ASA 4g/day enema through TET for 1 week; 200ml fecal microbiota suspension infusion through TET for 3 times every other day in one week
Drug: fecal microbiota transplantation
Fecal microbiota which was purified from fresh stool defecated by a healthy donor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical remission
Time Frame: 12 weeks
Total Mayo score less than 2 and no signal item more than 1
12 weeks
Clinical improvement
Time Frame: 12 weeks
Total Mayo score decreased more than 3 or decreased more than 30%
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intestinal microbiota changing
Time Frame: 12 weeks
The change of intestinal microbiota composition after FMT compared with subject original microbiota and donor's microbiota
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second Hospital of Nanjing Medical University

Collaborators

Zhongshan Hospital Xiamen University
Air Force Military Medical University, China
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
First Hospital of Guangzhou

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

December 13, 2016

First Submitted That Met QC Criteria

December 15, 2016

First Posted (Estimate)

December 20, 2016

Study Record Updates

Last Update Posted (Estimate)

December 20, 2016

Last Update Submitted That Met QC Criteria

December 15, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMT-UC-121101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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