The Gut Microbiome and Metabolomics Among Chronic Lower Extremities Threatening Ischemia Patients in China - a Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Bacteria or metabolites associated with prolonged survival time without above-knee amputation
研究概览
简要总结
Intestinal floras and their metabolites are involved in progressing metabolic and cardiovascular diseases. However, currently, articles related to the relationship between intestinal floras and atherosclerosis mainly focus on coronary atherosclerotic disease (CAD) population, or atherosclerosis model animals such as ApoE-/-, LDLR-/- high-fat diet mice, and there are few studies on Chronic limb-threatening ischemia (CLTI). CLTI and CAD have a similar pathological basis of atherosclerosis. It is unclear whether intestinal flora plays an essential role in the occurrence and development of CLTI. This project aims to explore the relation between microorganisms, metabolites, and CLTI.
详细描述
This project aims to study the intestinal flora and its metabolites in patients with CLTI, explore whether CLTI patients and CAD patients have their own characteristic flora, analyze the microorganisms and metabolites markers of poor prognosis in patients with CLTI, and screen out the key differential bacteria and metabolites that inhibit the progress of CLTI, in order to provide new insights and research basis for the treatment of CLTI.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Control group: sex - and age-matched healthy people (without history of atherosclerotic plaque, coronary heart disease or stroke).
- •Case group: resting pain for at least 2 weeks with at least one hemodynamic index: ABI<0.4,AP<50mmHg, TP or TCPO2<30mmHg. Tissue defects (ulceration or gangrene) persisted for at least 2 weeks with at least one significant PAD objective evidence: ABI<0.8, AP<100mmHg, TP or TCPO2<60mmHg.
排除标准
- •Patients with inflammatory bowel disease, autoimmune diseases, malignancies, infectious diseases, and severe liver and kidney dysfunction (cirrhosis, CKD stage 4 and 5).
- •Patients with thromboembolic angiitis, arterial embolism, and takayasu.
- •Patients who have used probiotics or antibiotics in the last 2 months.
- •After interventional surgery and amputation below the knee or above knee.
结局指标
主要结局
Bacteria or metabolites associated with prolonged survival time without above-knee amputation
时间窗: 3years.
The relationship between the prognosis and gut microbiota or plasma metabolomics was analyzed. Spearman correlations between CAGs, serum metabolite modules and clinical parameters were calculated using R, and both differential abundances of CAGs and CLTI-associated metabotypes were tested by the Wilcoxon rank sum test.
次要结局
- Key plasma metabolites in CLTI(up to 1 week)
- Key bacteria in CLTI(up to 1 week)