Clinical Efficacy and Safety of Fecal Microbiota Transplantation
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Set up a FMT registry
研究概览
简要总结
Changes in the fecal microbiota are known to be involved in the etiology of several diseases. The purpose of this study is to evaluate the effectiveness and safety of fecal microbiota transplantation (FMT) in diseases known to be associated with intestinal microbial inbalance. .
详细描述
This registry will prospectively enroll 300 patients who undergo fecal microbiota transplantation(FMT) at 3 clinical center (Yeungnam university mecial center, Kyungpook national university hospital, Keimyung university dongsan medical center). Feces received from healthy donors are prepared as frozen feces according to a standardized protocol, and transplanted to recipients within 3 months. Next generation sequencing(NGS) is used to check the characteristics of the fecal microbiota of the donor stool, and to evaluate the efficacy by checking the change in the fecal microbium of recipient before and after transplantation. The data is documented for following diseases known to be related to microbium imbalance.
- Recurrent or Refractory CDI Abdominal symptoms questionnaires, blood laboratory test(CBC, CRP, protein/albumin, AST/ALT, GTP, Total bilirubin/Direct bilirubin)
- Irritable bowel syndrome, Functional dyspepsia Abdominal symptoms questionnaires, IBS diagnosis and food-related questionnaires, blood laboratory test(CBC, CRP, protein/albumin, AST/ALT, GTP, Total bilirubin/Direct bilirubin)
- Inflammatory Bowel Disease Abdominal symptoms questionnaires, blood laboratory test(CBC, CRP, protein/albumin, AST/ALT, GTP, Total bilirubin/Direct bilirubin), fecal calprotectin, Colonoscopic examination(Mayo endoscopic subscore, CD-SES)
- Non-alcoholic steatohepatitis, NASH Abdominal symptoms questionnaires, blood laboratory test(CBC, CRP, protein/albumin, AST/ALT, GTP, Total bilirubin/Direct bilirubin), BMI check
- Obesity Abdominal symptoms questionnaires, blood laboratory test(CBC, CRP, protein/albumin, AST/ALT, GTP, Total bilirubin/Direct bilirubin), BMI check
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Those who have been diagnosed with disease to be studied and do not respond to exist treatments
- •Ulcerative colitis, Crohn disease : Patient who does not responding to anti- TNF treatment for more than 3 month.
- •Irritable bowel syndrome, Functional dyspepsia : Patient who does not responding to pharmacological therapies and serotonin uptake inhibitor for more than 6 month.
- •Recurrent of Refractory CDI, NASH, Obesity : Patient who does not responding to treatment for more than 6 month.
排除标准
- •Neutrophil (<0.5 x 10*9/L)
- •Leukocytosis (> 30.0 x 10*9/L)
- •Toxic megacolon confirmed in abdomen Xray
- •Pregnant or lactating women
结局指标
主要结局
Set up a FMT registry
时间窗: 3 years
Set up a registry of FMT in diseases known to be associated with intestinal microbial imbalance
次要结局
- Patient outcome of FMT(6 month)
- Developing biobank of FMT(3 Years)
研究者
YooJin Lee
Assistant Professor
Keimyung University Dongsan Medical Center