The Influence of a Symptomatic Coronary Artery and Peripheral Arterial Disease on the Oral-enteral Microbiome and Downstream Microbiome-dependent Metabolites
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change of enteral microbiome composition after presentation with ACS/CCS/CLI
研究概览
简要总结
Atherosclerotic diseases such as coronary artery disease (CAD) and peripheral arterial disease (PAD) are the leading cause of morbidity and mortality in the industrialized world.
An interaction between the development of atherosclerotic diseases and the oral and enteral microbiome composition has already been demonstrated in the past. The microbiome is a double-edged sword which can convey protective and detrimental cardiovascular effects. While it can promote the development of atherosclerosis through the production of atherogenic metabolites such as trimethylamine N-oxide (TMAO) it can also generate a protective effect through the production of metabolites such as short chain fatty acids (SCFA). Preliminary data suggest that atherosclerotic disease itself can induce a dysbiosis of the microbiome.
Aim of this study is to determine the differences in coronary artery disease and peripheral arterial disease on the oral-enteral microbiome axis and downstream microbiome-dependent metabolites.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 years
- •patient consent
- •CCS, ACS or CLI
- •angiographical confirmed peripheral or coronary artery disease
排除标准
- •pregnancy/lactation period
- •current antibiotic treatment or in the past 3 months
- •chronic inflammatory bowel disease
- •short bowel syndrome
- •artificial bowel outlet
- •persistent diarrhea or vomiting in the past 3 months
- •simultaneous participation in another interfering nutrition study
- •active chemo or radiation therapy
结局指标
主要结局
Change of enteral microbiome composition after presentation with ACS/CCS/CLI
时间窗: Sampling will be performed within 24 hours of presentation to the clinic, at day 3, day 7, day 14 and at day 28 (+/- 2 days) after initial presentation.
Stool samples are collected at the below mentioned time points. DNA isolation will be performed with consecutive 16S-RNA analysis and cluster analysis.
Change of oral microbiome composition after presentation with ACS/CCS/CLI
时间窗: Sampling will be performed within 24 hours of presentation to the clinic, at day 3, day 7, day 14 and at day 28 (+/- 2 days) after initial presentation.
Oral samples are collected at the below mentioned time points. DNA isolation will be performed with consecutive 16S-RNA analysis and cluster analysis.
次要结局
- Change of TMAO serum levels after presentation with ACS/CCS/CLI(Sampling will be performed within 24 hours of presentation to the clinic and at day 28 (+/- 2 days) after initial presentation.)
- Change of SCFA serum levels after presentation with ACS/CCS/CLI(Sampling will be performed within 24 hours of presentation to the clinic and at day 28 (+/- 2 days) after initial presentation.)
研究者
Chistos Rammos
Professor Dr. med.
University Hospital, Essen