Effect of Transjugular Intrahepatic Portosystemic Shunt on Gut Microbiota and Associated Inflammatory Factors in Cirrhotic Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Changes in fecal microbiota
研究概览
简要总结
The purpose of this study is to determine the effect of transjugular intrahepatic portosystemic shunt on gut microbiota and associated inflammatory factors in cirrhotic patients.
详细描述
Cirrhosis is associated with qualitative and quantitative changes in the gut microbiota that can potentiate disease progression and complications such as hepatic encephalopathy (HE) and infections. Dysbiosis or altered gut microbiota, due to decreased autochthonous or commensal taxa, has been found in stool and colonic mucosa in cirrhotic patients, which is in turn linked with disease severity and systemic inflammation.
TIPS can decompress the hypertensive portal vein,so that the intestinal congestion can be decrease too. Hence we summarize that TIPS may have effect on gut microbiota and associated inflammatory factors in cirrhotic patients.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cirrhotic patients who received TIPS;
- •Treatment-naive to TIPS and major operation involving liver such as surgical shunt, hepatic resection and liver transplantation)
排除标准
- •Uncontrolled infection or sepsis;
- •Hepatobiliary or pancreatic malignancy or biliary obstruction;
- •Vital organ dysfunction;
- •Administration of antibiotics (after TIPS and 2 weeks before TIPS);
- •Cachexia;
- •Pregnant or breeding women
结局指标
主要结局
Changes in fecal microbiota
时间窗: baseline and 6 month
次要结局
- Incidence of hepatic encephalopathy(6 month)
- Changes of blood inflammatory parameter including IL-2（interleukin 2）,IL-6,IL-10,IL-8，TNF-α(baseline and 6 month)
研究者
Wang Zhu, MD
Medical Doctor
West China Hospital