Fecal Microbiota Transplantation and Analysis of Fecal Microbiome in IBD Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Clinical remission
研究概览
简要总结
Fecal microbiome of donor and recipient will be analyzed before and after fecal microbiota transplantation in IBD patients.
详细描述
Fecal microbiota transplantation will be performed to the IBD patients, and microbial analysis will be done for donor and recipient feces. Fecal microbiota transplantation will be done twice via colonoscopy, with one month of duration. During the early stage of Fecal microbiota transplantation, recipient feces will be analyzed for the intestinal microbiota frequently.
Clinical outcome will be assessed 1month, 2month, 6month, and 1 year after the transplantation.
Relevance of intestinal microbial change and clinical outcome after transplantation and factors associated with successful clinical outcome will be investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •7 years old to 80 years old at start of trial
- •Inflammatory bowel disease such as ulcerative colitis, Crohn's disease, and Behcet's colitis
- •Patients who do not respond to the conventional treatments or who do not wish/not able to use one.
- •Patients who agree to participate in the trial after thorough explanation
- •Evidence of active disease
排除标准
- •Patients whose CRP<8, calprotectin<200, and mucosal healing endoscopically (who are in stable state)
- •Patients whose symptom is due to other disease than IBD
- •_Patients with immunosuppressive disease
- •Patients who are clinically unstable such as massive hemorrhage or perforation
- •Patients with toxic megacolon, paralytic ileus, or symptomatic intestinal obstruction
- •Absolute neutrophil count (ANC) <1.5 *10^9/L (1500/mm3)
- •Pregnant or under breast feeding
- •Patients enrolled in other clinical trials
研究组 & 干预措施
FMT group
Group who received fecal microbiome transplantation
干预措施: Fecal microbiome transplantation (Procedure)
结局指标
主要结局
Clinical remission
时间窗: 6months after the Second FMT
For Ulcerative Colitis patients Patients 18 years old and under: Pediatric ulcerative colitis activity index (PUCAI) less than 10. It ranges from 0 to 85, with a higher score indicating greater severity of disease Patients over 18 years old: Partial Mayo score same or less than 1 It ranges from 0 to 9, with a higher score indicating greater severity of disease For Crohn's Disease patients Patients 18 years old and under: Pediatric Crohn's disease activity index (PCDAI) less than 10 It ranges from 0 to 100, with a higher score indicating greater severity of disease Patients over 18 years old: Crohn's disease activity index (CDAI) less than 150 It ranges from 0 to over 600, with a higher score indicating greater severity of disease
次要结局
- Adverse events(6 months after the Second FMT)
- Microbiome analysis by using relative abundance at phylum and genus level, beta diversity(Before, day 0~28 of 1st FMT, day 0~28, 60, 90, 180 of 2nd FMT)
- Clinical response using disease activity index(6 months after the Second FMT)
- Endoscopic healing(4 weeks after the First FMT)