Fecal Microbiota Transplantation for Ulcerative Colitis Through Colonic Transendoscopic Enteral Tubing
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- Clinical remission
研究概览
简要总结
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.
详细描述
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active, moderate to severe severity (Mayo score more than 6)
- •Safety using history of 5-ASA.
- •Able to undergo endoscopy examination.
排除标准
- •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)
研究组 & 干预措施
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
干预措施: Saline (Drug)
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
干预措施: fecal microbiota transplantation (Drug)
结局指标
主要结局
Clinical remission
时间窗: 12 weeks
Total Mayo score less than 2 and no signal item more than 1
Clinical improvement
时间窗: 12 weeks
Total Mayo score decreased more than 3 or decreased more than 30%
次要结局
- Intestinal microbiota changing(12 weeks)
研究者
Faming Zhang
Associate professor, Gastroenterology
The Second Hospital of Nanjing Medical University