Efficacy and Safety of Fecal Microbiota Transplantation for Ulcerative Colitis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Clinical remission in patient as assessed using Mayo score
研究概览
简要总结
Fecal microbiota transplantation (FMT) is a strategy that infuses a fecal suspension containing a healthy donor's microbiota into a patient's gut to restore his/her intestinal microbiome. Fecal microbiota transplantation has been used for several disease，but the efficacy of ulcerative colitis(UC) by fecal microbiota transplantation needs to be further explored.The investigators propose to determine the efficiency and safety of FMT in patients with ulcerative colitis(UC).
详细描述
The present clinical trial aims to re-establish a gut functionality state of intestinal flora through FMT as a therapy for ulcerative colitis(UC). We established a standard microbiota isolation from donated fresh stool in lab. Then the microbiota is transplanted to the intestine. Patients from Guangzhou First People's Hospital in this study will be assigned to receive FMT at least two times according to associated guidelines and follow-up for at least three months.
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
- •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
Fecal microbiota transplantation
Fecal microbiota transplantation
干预措施: Fecal microbiota transplantation (Procedure)
Fecal microbiota transplantation
Fecal microbiota transplantation
干预措施: 5-Aminosalicylic acid(5-ASA) and/or Prednisone (Drug)
placebo fecal microbiota transplantation
Infusion of Saline
干预措施: Infusion of Saline (Procedure)
placebo fecal microbiota transplantation
Infusion of Saline
干预措施: 5-Aminosalicylic acid(5-ASA) and/or Prednisone (Drug)
Traditional treatments
Drug:5-Aminosalicylic acid(5-ASA) and/or Prednisone
干预措施: 5-Aminosalicylic acid(5-ASA) and/or Prednisone (Drug)
结局指标
主要结局
Clinical remission in patient as assessed using Mayo score
时间窗: 12 weeks
Total Mayo score less than 2 and no signal item more than 1
Clinical improvement in patient as assessed using Mayo score
时间窗: 12 weeks
Total Mayo score decreased more than 3
次要结局
- Intestinal microbiota changing(12 weeks)