Fecal Microbiota Transplantation for Ulcerative Colitis Through Colonic Transendoscopic Enteral Tubing
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|ClinicalTrials.gov Identifier: NCT02998112|
Recruitment Status : Recruiting
First Posted : December 20, 2016
Last Update Posted : December 20, 2016
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Drug: fecal microbiota transplantation Drug: Saline||Phase 4|
- Patients with moderate to severe UC will be screened (Mayo>6）.
- Participants will be divided into control and study groups by double blind.
- Control group and study group will receive a colonic endoscopy evaluation. And a TET tube will be fixed at ileocecum.
- 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.
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||188 participants|
|Intervention Model:||Parallel Assignment|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||July 2017|
|Estimated Study Completion Date :||December 2017|
Placebo Comparator: 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
Experimental: 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
Drug: fecal microbiota transplantation
Fecal microbiota which was purified from fresh stool defecated by a healthy donor
- Clinical remission [ Time Frame: 12 weeks ]Total Mayo score less than 2 and no signal item more than 1
- Clinical improvement [ Time Frame: 12 weeks ]Total Mayo score decreased more than 3 or decreased more than 30%
- Intestinal microbiota changing [ Time Frame: 12 weeks ]The change of intestinal microbiota composition after FMT compared with subject original microbiota and donor's microbiota
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02998112
|Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University||Recruiting|
|Nanjing, Jiangsu, China, 210011|
|Contact: Faming Zhang, MD, PhD 086-25-58509883 email@example.com|