Fecal Microbiota Transplantation for Ulcerative Colitis Through Colonic Transendoscopic Enteral Tubing
NCT ID: NCT02998112
Last Updated: 2016-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
188 participants
INTERVENTIONAL
2016-12-31
2017-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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
Saline
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
fecal microbiota transplantation
Fecal microbiota which was purified from fresh stool defecated by a healthy donor
Interventions
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fecal microbiota transplantation
Fecal microbiota which was purified from fresh stool defecated by a healthy donor
Saline
Eligibility Criteria
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Inclusion Criteria
* Safety using history of 5-ASA.
* Able to undergo endoscopy examination.
Exclusion Criteria
* 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)
18 Years
65 Years
ALL
No
Sponsors
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Air Force Military Medical University, China
OTHER
First Hospital of Guangzhou
UNKNOWN
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
OTHER
Zhongshan Hospital Xiamen University
OTHER
The Second Hospital of Nanjing Medical University
OTHER
Responsible Party
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Faming Zhang
Associate professor, Gastroenterology
Locations
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Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Countries
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Facility Contacts
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Faming Zhang, MD, PhD
Role: primary
References
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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: 10.1186/s12967-015-0646-2.
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 Hepatol. 2015 Jan;30(1):51-8. doi: 10.1111/jgh.12727.
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. Gastroenterology. 2015 Jul;149(1):102-109.e6. doi: 10.1053/j.gastro.2015.04.001. Epub 2015 Apr 7.
Rossen NG, Fuentes S, van der Spek MJ, Tijssen JG, Hartman JH, Duflou A, Lowenberg 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 With Ulcerative Colitis. Gastroenterology. 2015 Jul;149(1):110-118.e4. doi: 10.1053/j.gastro.2015.03.045. Epub 2015 Mar 30.
Other Identifiers
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FMT-UC-121101
Identifier Type: -
Identifier Source: org_study_id