The Study of HIF-1α in Cirrhosis by Fecal Microbiota Transplantation
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- white blood cell
研究概览
简要总结
Patients with cirrhosis were recruitted and divided into cintrol group and FMT group. Patients in FMT group were carried by fecal microbiota transplantation, and biochemical indexes, intestinal flora and intestinal HIF expression were observed before and after FMT respectively.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of cirrhotic
- •aged 18-80 years.
- •must be able to cooperate with treatment
排除标准
- •Patients with severe cardiac, pulmonary and renal dysfunction;
- •Patients with severe hypertension and cerebrovascular accidents;
- •Patients with liver cancer or active infection are in the active stage of hepatic encephalopathy or gastrointestinal bleeding;
- •Prothrombin activity ≤40%, platelet count < 50*10^9/L;
- •Patients with intellectual and language disorders and mental disorders;
- •Probiotics with antibiotic and drug grade were used within 3 months prior to sampling;
- •There are prehepatic or posthepatic portal hypertension reasons;
- •Drug history: anticoagulant therapy, use of antiplatelet drugs, and current use of beta blockers, statins or interferon (IFN) treatment;
- •Peptic colon examination contraindications, such as intestinal perforation, intestinal obstruction, etc.
- •Other researchers believe that patients should not be included in the group.
结局指标
主要结局
white blood cell
时间窗: Change from baseline white blood cell at 12 months
white blood cell in /L
albumin
时间窗: Change from baseline albumin at 12 months
albumin in g/L
blood ammonia
时间窗: Change from baseline blood ammonia at 12 months
blood ammonia in umol/L
alanine aminotransferase
时间窗: Change from baseline alanine aminotransferase at 12 months
alanine aminotransferase in U/L
prothrombin time activity percentage
时间窗: Change from baseline prothrombin time activity percentage at 12 months
prothrombin time activity percentage in %
hemoglobin
时间窗: Change from baseline hemoglobin at 12 months
hemoglobin in g/L
aspartate aminotransferase
时间窗: Change from baseline aspartate aminotransferase at 12 months
aspartate aminotransferase in U/L
gut microbiome
时间窗: Change from baseline gut microbiome at 12 months
16S RNA sequencing in gut microbiome
blood platelet
时间窗: Change from baseline blood platelet at 12 months
blood platelet in/L
blood glucose
时间窗: Change from baseline blood glucose at 12 months
blood glucose in mmol/L
Serum creatinine
时间窗: Change from baseline serum creatinine at 12 months
Serum creatinine in umol/L
direct bilirubin
时间窗: Change from baseline direct bilirubin at 12 months
direct bilirubin in umol/L
indirect bilirubin
时间窗: Change from baseline indirect bilirubin at 12 months
indirect bilirubin in umol/L
liver stiffness
时间窗: Change from baseline liver stiffness at 12 months
liver stiffness in Kpa
次要结局
- Concentration of HIF-1α in intestine(Change from baseline HIF-1α expression in intestine at 12 months)