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Fecal Microbiota Transplantation for Ulcerative Colitis Through Colonic Transendoscopic Enteral Tubing

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2016 by The Second Hospital of Nanjing Medical University
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT02998112
First received: December 13, 2016
Last updated: December 15, 2016
Last verified: December 2016
  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 Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: December 13, 2016
Last Updated: December 15, 2016

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

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

ClinicalTrials.gov processed this record on March 29, 2017