Exploring the Mechanism of Severe Acute Pancreatitis Based on Metagenomics, Metabolomics and Proteomics
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Composition of gut metabolites
研究概览
简要总结
The goal of this observational study is to learn about the biomarkers and mechanisms of severe acute pancreatitis in 30 healthy controls, 30 patients of mild acute pancreatitis, 30 patients of moderately severe acute pancreatitis, and 86 patients of severe acute pancreatitis. The main question it aims to answer are: • The relationship between changes in gut microbiota and clinical prognosis (plasma inflammatory cytokines, incidence and duration of infection in various parts, mortality rate), and the screening and validation of biomarkers that can be used for early prediction of disease severity. • Analyze the relationship between changes in blood composition and clinical prognosis (plasma inflammatory cytokines, incidence and duration of infection in various parts, mortality rate), screen and verify biomarkers that can be used for early prediction of disease severity. Blood and fecal samples from the healthy control group and diagnosed patients will be collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •Patients group:
- •① Age between 18 and 75 years old;
- •② Within 72 hours of AP onset;
- •③ AP patients who meet the 2012 Atlanta AP Classification and Diagnostic Criteria.
- •Healthy control group:
- •Age between 18 and 75 years old; ② No history of acute pancreatitis; ③ Routine laboratory tests such as blood routine and fecal routine are normal.
排除标准
- •Used antibiotics, probiotics, and acid suppressants 4 weeks before enrollment;
- •Pregnant and lactating women;
- •Hypothyroidism, nephrotic syndrome, Cushing's syndrome, AIDS;
- •Chronic pancreatitis, pancreatic cancer; ⑤ Severe history of cardiovascular and cerebrovascular diseases and organ dysfunction, such as malignant tumors, heart failure, coronary heart disease, chronic obstructive pulmonary disease, liver and kidney failure; ⑥ Unsigned informed consent form.
结局指标
主要结局
Composition of gut metabolites
时间窗: through study completion, an average of 1 year
Metabolites can reveal the intrinsic correlation between metabolic products and physiological and pathological changes in the body, thereby achieving recognition of the overall state of the body.
Composition of gut microbiota
时间窗: through study completion, an average of 1 year
The gut microbiota plays an important role in protecting the intestinal barrier, regulating metabolism, and participating in immune responses in the human body, and is an important component of the gut ecosystem.
Composition of metabolites in plasma
时间窗: through study completion, an average of 1 year
Metabolites can reveal the intrinsic correlation between metabolic products and physiological and pathological changes in the body, thereby achieving recognition of the overall state of the body.
composition of proteins in plasma
时间窗: through study completion, an average of 1 year
Proteins are an important material foundation for life activities and the main executors of life processes such as cell proliferation, differentiation, aging, and death.
次要结局
未报告次要终点
研究者
Lingyu Luo
Professor
The First Affiliated Hospital of Nanchang University