Alterations of Gut Microbiota and Serum Biochemical Markers in Asian Patients With Drug-induced Liver Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The changes of gut microbiota in the levels of phylum, genus, and species in two groups
研究概览
简要总结
Drug-induced liver injury is a leading cause of acute liver failure worldwide and one of the least understood areas in hepatology research. Increasing evidence has shown that drug-induced liver injury is associated with gut microbiota.
详细描述
Background:
Drug-induced liver injury(DILI) refers to the liver injury induced by all kinds of drugs and is the leading cause of acute liver failure worldwide. China has a large population base and a wide variety of clinical drugs, and it is common for the population to use drugs irregularly. Therefore, the incidence of DILI is increasing year by year. The pathogenesis of DILI is complicated, and there are often multiple mechanisms successively or altogether. As a result of the same effect, it is particularly important to study the pathogenesis of DILI and find its therapeutic target. Increasing evidence shows that DILI is related to the gut microbiota, which provides broader insights and opportunities for understanding and treating this disease.
Aims:
We aim to map the alterations of gut microbiota and serum biochemical markers in patients with DILI, and to investigate the effects and mechanisms of key strains on the development of DILI, providing a theoretical basis and potential targets for its treatment.
Methods:
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The group of DILI:
- •aged >18 years;
- •patients who meet the diagnostic criteria of DILI in Guidelines for Diagnosis and Treatment of Drug-induced Liver Injury;
- •history of taking hepatotoxic drugs;
- •with relatively complete clinical data and good compliance.
- •The group of healthy control:
- •aged >18 years;
- •no history of liver disease and other diseases.
排除标准
- •with hepatocellular carcinoma (HCC) or hepatic metastases;
- •combined with infectious liver diseases, such as hepatitis A virus, hepatitis B virus, hepatitis C virus, hepatitis D virus, hepatitis E virus, and human immunodeficiency virus (HIV);
- •combined with non-infectious liver diseases, such as non-alcoholic fatty liver disease, alcoholic liver disease, autoimmune liver disease, immunoglobulin G4-related liver disease, Wilson's disease, alpha 1-antitrypsin deficiency, Budd-Chiari syndrome, and other congenital liver diseases;
- •combined with severe organic lesions of other organs;
- •pregnant and lactating women.
结局指标
主要结局
The changes of gut microbiota in the levels of phylum, genus, and species in two groups
时间窗: 2 years
The changes will be detected by genome sequencing
The different levels of serum aspartate transaminase/alanine transaminase (AST/ALT) in two groups
时间窗: 2 years
The changes will be detected by biochemical analyzers
The different levels of proinflammatory cytokines in two groups
时间窗: 2 years
The changes will be determined by ELISA kits
The changes of lncRNA and miRNA in two groups
时间窗: 2 years
The changes will be measured by quantitative polymerase chain reaction (qPCR)
次要结局
未报告次要终点
研究者
Huikuan Chu, MD
Associate chief physician
Wuhan Union Hospital, China