Fecal Microbiota Transplantation for Ulcerative Colitis Through Colonic Transendoscopic Enteral Tubing

Ulcerative Colitis Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02998112
• Other study ID #: FMT-UC-121101
• Status: Recruiting
• Phase: Phase 4
• First received: December 13, 2016
• Last updated: December 15, 2016
• Start date: December 2016
• Est. completion date: December 2017

Study information

• Verified date: December 2016
• Source: The Second Hospital of Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 188
• Est. completion date: December 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• fecal microbiota transplantation
Fecal microbiota which was purified from fresh stool defecated by a healthy donor
• Saline

Locations

Country	Name	City	State
China	Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (5)

Lead Sponsor	Collaborator
The Second Hospital of Nanjing Medical University	Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, First Hospital of Guangzhou, Fourth Military Medical University, Zhongshan Hospital Xiamen University

Country where clinical trial is conducted

China, 

References & Publications (4)

Cui B, Feng Q, Wang H, Wang M, Peng Z, Li P, Huang G, Liu Z, Wu P, Fan Z, Ji G, Wang X, Wu K, Fan D, Zhang F. Fecal microbiota transplantation through mid-gut for refractory Crohn's disease: safety, feasibility, and efficacy trial results. J Gastroenterol — View Citation

Cui B, Li P, Xu L, Zhao Y, Wang H, Peng Z, Xu H, Xiang J, He Z, Zhang T, Nie Y, Wu K, Fan D, Ji G, Zhang F. Step-up fecal microbiota transplantation strategy: a pilot study for steroid-dependent ulcerative colitis. J Transl Med. 2015 Sep 12;13:298. doi: 1 — View Citation

Moayyedi P, Surette MG, Kim PT, Libertucci J, Wolfe M, Onischi C, Armstrong D, Marshall JK, Kassam Z, Reinisch W, Lee CH. Fecal Microbiota Transplantation Induces Remission in Patients With Active Ulcerative Colitis in a Randomized Controlled Trial. Gastr — View Citation

Rossen NG, Fuentes S, van der Spek MJ, Tijssen JG, Hartman JH, Duflou A, Löwenberg M, van den Brink GR, Mathus-Vliegen EM, de Vos WM, Zoetendal EG, D'Haens GR, Ponsioen CY. Findings From a Randomized Controlled Trial of Fecal Transplantation for Patients — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical remission	Total Mayo score less than 2 and no signal item more than 1	12 weeks	Yes
Primary	Clinical improvement	Total Mayo score decreased more than 3 or decreased more than 30%	12 weeks	Yes
Secondary	Intestinal microbiota changing	The change of intestinal microbiota composition after FMT compared with subject original microbiota and donor's microbiota	12 weeks	No