Fecal Microbiota Transplantation for Ulcerative Colitis

January 12, 2019 updated by: Guangzhou First People's Hospital

Efficacy and Safety of Fecal Microbiota Transplantation for Ulcerative Colitis

Fecal microbiota transplantation (FMT) is a strategy that infuses a fecal suspension containing a healthy donor's microbiota into a patient's gut to restore his/her intestinal microbiome. Fecal microbiota transplantation has been used for several disease，but the efficacy of ulcerative colitis(UC) by fecal microbiota transplantation needs to be further explored.The investigators propose to determine the efficiency and safety of FMT in patients with ulcerative colitis(UC).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The present clinical trial aims to re-establish a gut functionality state of intestinal flora through FMT as a therapy for ulcerative colitis(UC). We established a standard microbiota isolation from donated fresh stool in lab. Then the microbiota is transplanted to the intestine. Patients from Guangzhou First People's Hospital in this study will be assigned to receive FMT at least two times according to associated guidelines and follow-up for at least three months.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Guangzhou First People's Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Haoming Xu, MM

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:

  • 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
Experimental: Fecal microbiota transplantation
Procedure: Fecal microbiota transplantation
200 mL of prepared fecal microbiota suspension from healthy donors' fresh feces was injected into the intestine
Drug: 5-Aminosalicylic acid(5-ASA) and/or Prednisone
Mesalazine and/or Prednisone
Other Names:
  • Prednisone
  • Mesalazine
Sham Comparator: placebo fecal microbiota transplantation
Infusion of Saline
Drug: 5-Aminosalicylic acid(5-ASA) and/or Prednisone
Mesalazine and/or Prednisone
Other Names:
  • Prednisone
  • Mesalazine
Procedure: Infusion of Saline
Infusion of Saline
Other: Traditional treatments
Drug:5-Aminosalicylic acid(5-ASA) and/or Prednisone
Drug: 5-Aminosalicylic acid(5-ASA) and/or Prednisone
Mesalazine and/or Prednisone
Other Names:
  • Prednisone
  • Mesalazine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical remission in patient as assessed using Mayo score
Time Frame: 12 weeks
Total Mayo score less than 2 and no signal item more than 1
12 weeks
Clinical improvement in patient as assessed using Mayo score
Time Frame: 12 weeks
Total Mayo score decreased more than 3
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

Guangzhou First People's Hospital

Investigators

  • Principal Investigator: Yuqiang Nie, MD, Guangzhou First People's Hospital

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 (Anticipated)

January 20, 2019

Primary Completion (Anticipated)

December 31, 2028

Study Completion (Anticipated)

December 31, 2030

Study Registration Dates

First Submitted

January 6, 2019

First Submitted That Met QC Criteria

January 12, 2019

First Posted (Actual)

January 15, 2019

Study Record Updates

Last Update Posted (Actual)

January 15, 2019

Last Update Submitted That Met QC Criteria

January 12, 2019

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K-2017-103-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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