Fecal Microbiota Transplantation for Ulcerative Colitis Through Colonic Transendoscopic Enteral Tubing

Phase 4

• Conditions: Ulcerative Colitis
• Interventions: Drug: Saline; Drug: fecal microbiota transplantation

• Registration Number: NCT02998112
• Lead Sponsor: The Second Hospital of Nanjing Medical University

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.

Study Timeline

• Status Verified: 2016-12
• Study Start: 2016-12
• Study First Submitted: 2016-12-13
• Study First Submitted QC: 2016-12-15
• Last Update Submitted: 2016-12-15
• Study First Posted: 2016-12-20
• Last Update Posted: 2016-12-20
• Primary Completion: 2017-07
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 188

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	Saline	5-ASA 4g/day enema through TET for 1 week; 200ml saline infusion through TET for 3 times every other day in one week
Study group	fecal microbiota transplantation	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Intestinal microbiota changing	12 weeks	The change of intestinal microbiota composition after FMT compared with subject original microbiota and donor's microbiota

Trial Locations

Locations (1)

Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China