Efficacy, Durability and Safety of Standardized Fecal Microbiota Transplantation for Severe Inflammatory Bowel Disease
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Clinical remission (defined as HBI score ≦ 4)
研究概览
简要总结
There are many limitations in the current treatments of Inflammatory bowel disease (IBD). Now the investigators realized that the intestinal microecological is closely associated with the development 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 will recruit 40 patients with IBD (20 cases of Ulcerative Colitis and 20 cases of Crohn's disease) in China. The patients will be randomly divided into 2 groups, one group will be given treatment of standardized fecal microbiota transplantation, the other will be simply treated with mesalazine, followed up for at least 1 year. The investigators propose to determine the efficiency, durability and safety of Standardized Fecal Microbiota Transplantation for IBD treatment.
详细描述
In this projects the investigators aim to re-establish a gut balance of intestinal microecological through Standardized Fecal Microbiota Transplantation for IBD (UC and CD). We will establish a standardized isolation, store, and transportion steps of fecal bacteria from donated fresh stool in the laboratory. Then the bacteria will be transplanted to mid-gut by nose-jejunum nutrition tube. Patients in this study will be assigned to receive standardized FMT only once or traditional medicine of mesalazine and would be followed up for at least 1 year. The clinical symptoms, sign, blood tests, abdominal CT, endoscopy and questionnaire will be used to assess the efficiency, durability and safety of Standardized FMT at the start and end of the projects.
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
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe IBD define as HBI score ≥
- •Moderate IBD define as 7<HBI <9
- •Montreal classification: Age > 14 years old, Location L1-3, Behavior B1-3.
排除标准
- •Diarrhea activity scores < 3
- •Severely active disease with perianal diseases
- •Severely active disease with indication of surgery.
- •Diagnosis as IBD first time or first year.
- •No history of using 5-ASA, biological (antibody), immunomodulatory therapy, corticosteroid therapy
研究组 & 干预措施
Mesalazine
This group include 20 patients . The patients will receive traditional medicine of mesalazine treatment.
干预措施: Mesalazine (Drug)
Standardized FMT
The group include 20 patients. They will receive standardized FMT. The FMT was given to mid-gut by nose-jejunum nutrition tube. It was given only once.
干预措施: FMT (Procedure)
结局指标
主要结局
Clinical remission (defined as HBI score ≦ 4)
时间窗: up to one year
Clinical remission defined as HBI score ≦ 4. The endpoint of follow-up is the time of clinical recurrence
次要结局
- Hospitalization days(up to one year)
研究者
Yanling Wei
Department of Gastroenterology, Research Institute of Surgery, Da ping Hospital, The Third Military Medical University
Third Military Medical University