A Multicenter Clinical Trial: Efficacy, Safety of Fecal Microbiota Transplantation for Inflammatory Bowel Disease
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Clinical remission: the modified Mayo score and endoscopy
研究概览
简要总结
There are many limitations in the current treatments of Inflammatory bowel disease(IBD). Some patients have no or little reaction to the traditional drugs. Now the investigators realized that the intestinal microbiota is closely associated with the development of IBD. In recent years, a retrospective study showed that the overall efficiency of fecal microbiota transplantation (FMT) for IBD was 79%, the overall remission rate was 43%, which opened a new chapter in the treatment of IBD. So the standardized fecal microbiota transplantation is considered to be simple but effective emerging therapies for the treatment of IBD. In this project the investigators intend to carry out a single-center, randomized, single-blind clinical intervention study. The investigators plan to recruit patients with IBD (Ulcerative Colitis and Crohn's Disease) in China. The patients will be randomly divided into two groups, one group will be given treatment of standardized fecal microbiota transplantation, the other will be simply treated with traditional drugs, followed up for at least 1 year. The investigators aim to determine the efficiency, durability and safety of Fecal Microbiota Transplantation for IBD treatment, and further to explore which major microbiota may effect in this project.
详细描述
In this projects the investigators aim to re-establish a gut balance of intestinal microbiota through Standardized Fecal Microbiota Transplantation for IBD (UC and CD). We have established a standardized isolation, store, and transport steps of fecal bacteria from donated fresh stool in the laboratory. Then the bacteria will be transplanted to mid-gut by capsule. Patients in this study will be assigned to receive standardized FMT three times or not and would be followed up for at least 1 year. The clinical symptoms, sign, blood tests, endoscopy and questionnaire will be used to assess the efficiency, durability and safety of Standardized FMT at the start and end of the projects. At last, we will use 16S-rDNA to estimate the change of intestinal microbiota.
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
- None
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
- 是
入选标准
- •Standard or conventional medicine treatment ineffective of IBD patients
- •IBD patients with recurrent symptoms
- •IBD patients who had drug dependence or recurrence when reduced or discontinued use
- •Untreated IBD patients who voluntarily received FMT
排除标准
- •IBD patients with contraindications for gastrointestinal endoscopy
- •IBD patients combined with other serious diseases such as respiratory failure, heart failure and severe immunodeficiency
- •IBD patients with indication of surgery
研究组 & 干预措施
Standardized FMT
The patients will receive standardized FMT. The FMT was given by capsule. It was given three times a week.
干预措施: fecal microbiota capsule (Drug)
Without FMT
The patients will receive FMT with blank capsule.
干预措施: fecal microbiota capsule (Drug)
结局指标
主要结局
Clinical remission: the modified Mayo score and endoscopy
时间窗: up to one year
Clinical remission defined as modified Mayo score≦2 (range 0-12). The endpoint of follow-up is the time of clinical recurrence. The higher scores mean a worse outcome.
次要结局
未报告次要终点