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Fecal Microbiota Transplantation for Ulcerative Colitis Through Colonic Transendoscopic Enteral Tubing

This study is currently recruiting participants.
Verified December 2016 by Faming Zhang, The Second Hospital of Nanjing Medical University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02998112
First Posted: December 20, 2016
Last Update Posted: December 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Fourth Military Medical University
First Hospital of Guangzhou
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Zhongshan Hospital Xiamen University
Information provided by (Responsible Party):
Faming Zhang, The Second Hospital of Nanjing Medical University
  Purpose
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.

Condition Intervention Phase
Ulcerative Colitis Drug: fecal microbiota transplantation Drug: Saline Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Faming Zhang, The Second Hospital of Nanjing Medical University:

Primary Outcome Measures:
  • Clinical remission [ Time Frame: 12 weeks ]
    Total Mayo score less than 2 and no signal item more than 1

  • Clinical improvement [ Time Frame: 12 weeks ]
    Total Mayo score decreased more than 3 or decreased more than 30%


Secondary Outcome Measures:
  • Intestinal microbiota changing [ Time Frame: 12 weeks ]
    The change of intestinal microbiota composition after FMT compared with subject original microbiota and donor's microbiota


Estimated Enrollment: 188
Study Start Date: December 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02998112


Locations
China, Jiangsu
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University Recruiting
Nanjing, Jiangsu, China, 210011
Contact: Faming Zhang, MD, PhD    086-25-58509883    fzhang@njmu.edu.cn   
Sponsors and Collaborators
The Second Hospital of Nanjing Medical University
Fourth Military Medical University
First Hospital of Guangzhou
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Zhongshan Hospital Xiamen University
  More Information

Publications:
Responsible Party: Faming Zhang, Associate professor, Gastroenterology, The Second Hospital of Nanjing Medical University
ClinicalTrials.gov Identifier: NCT02998112     History of Changes
Other Study ID Numbers: FMT-UC-121101
First Submitted: December 13, 2016
First Posted: December 20, 2016
Last Update Posted: December 20, 2016
Last Verified: December 2016

Keywords provided by Faming Zhang, The Second Hospital of Nanjing Medical University:
fecal microbiota transplantation
Ulcerative colitis

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases