Ulcerative Colitis
Conditions
Keywords
fecal microbiota transplantation, Ulcerative colitis
Brief summary
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.
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.
Interventions
DRUGfecal microbiota transplantation
Fecal microbiota which was purified from fresh stool defecated by a healthy donor
DRUGSaline
Sponsors
Air Force Military Medical University, China
First Hospital of Guangzhou
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Zhongshan Hospital Xiamen University
The Second Hospital of Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical remission | 12 weeks | Total Mayo score less than 2 and no signal item more than 1 |
| Clinical improvement | 12 weeks | Total Mayo score decreased more than 3 or decreased more than 30% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intestinal microbiota changing | 12 weeks | The change of intestinal microbiota composition after FMT compared with subject original microbiota and donor's microbiota |
Countries
China
Outcome results
None listed