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Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

NCT number NCT02998112
Study type Interventional
Source The Second Hospital of Nanjing Medical University
Status Recruiting
Phase Phase 4
Start date December 2016
Completion date December 2017

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