Alteration of Intestinal Microflora and Efficacy and Safety of Fecal Microbiota Transplantation for Severe Acute Pancreatitis
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Mortality
研究概览
简要总结
Severe acute pancreatitis is an acute and rapid progress of the digestive system disease.Most patients with severe pancreatitis associated with intestinal mucosal barrier dysfunction.Intestinal microflora,an important part of the intestinal mucosal barrier, play an important role in the development process in the course of severe acute pancreatitis. At this stage of the study that infection of pancreas and other organs is the leading cause of death in patients with severe acute pancreatitis，and the main pathogens from intestinal micro-organisms， but the intestinal flora changes did not be mentioned. Fecal Microbiota Transplantation that has been used for treatment of inflammatory bowel disease and Clostridium difficile infection may be a new technology for regulation of intestinal mucosal dysfunction and intestinal flora unbalance.
详细描述
Patients with acute pancreatitis will be assessed depending on APACHE II and CT score and all of them also will be separated into two parts depending on acceptation or refusal of FMT. Blood specimens from patients will be collected to analysis inflammatory factors，and fecal microbiota samples will be detection.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The diagnosis of acute pancreatitis: elevated serum amylase and/or lipase levels (more than 3-fold the upper reference limit) and evidence of pancreatitis on computed tomography (CT) of the abdomen;
- •No chronic diseases of the digestive system ;
- •No chronic diseases of the urinary system;
- •No chronic metabolic disease;
- •No chronic disease of immune system
- •No chronic disease of mental disease
- •no acute intestinal disease; taking antibiotics anti-inflammatory drugs and history of probiotics for one month;
- •No use of addictive drugs and immune inhibitors
排除标准
- •not to match the standard of AP
- •with chronic diseases of the digestive system;
- •with chronic diseases of the urinary system;
- •with chronic metabolic disease;
- •with chronic disease of immune system
- •with chronic disease of mental disease
- •with acute intestinal disease; taking antibiotics anti-inflammatory drugs and history of probiotics for one month;pregnancy and lactation women
- •with use of addictive drugs and immune inhibitors
- •exceed the age limits
结局指标
主要结局
Mortality
时间窗: 3 months
次要结局
- C-reactive protein（CRP）(2-4 weeks)
- Diamine oxidase（DAO）(2-4 weeks)
- Interleukin(2-4 weeks)
- tumor necrosis factor-a(TNF-a)(2-4 weeks)