A Study About Association Between Microbiome, Metabolome and Clinical Characteristics in COPD Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 主要终点
- Propionic acid level
研究概览
简要总结
The goal of this observational registry study is to compare characteristics of gut and sputum microbiome and metabolome among COPD patients with significant smoking history, COPD patients without significant smoking history and healthy smoker. Additionally, the investigators investigate the difference of blood metabolites and peripheral blood mononuclear cells level among groups.
The main questions it aims to answer are:
- Are there significant difference in fecal or sputum microbiome and metabolome between COPD patients and healthy smoker?
- Are there any distinct characteristics in microbiome and metabolome in COPD with COPD patients with significant smoking history, COPD patients without significant smoking history compared with healthy smoker?
- Are there any difference in blood metabolites and peripheral blood mononuclear cells levels among patients with significant smoking history, COPD patients without significant smoking history and healthy smoker
- Might distinct characteristics of microbiome and metabolites in COPD patients be related to worse clinical outcomes in COPD patients?
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •COPD Patients, defined by FEV1/FVC <0.7, who
- •agree with informed consent
- •have no history of acute exacerbation within 3 months
- •Healthy smoker without airflow limitation, defined by FEV1/FVC ≥0.7, who
- •have smoking history with at least 30 pack-year
- •agree with informed consent
- •do not use medication for chronic respiratory disease
排除标准
- •Withdrawal of informed consent
- •History of acute exacerbation or antibiotics use within 3 months
- •Difficulty to collect adequate stool, sputum and blood samples
结局指标
主要结局
Propionic acid level
时间窗: At enrollment
the investigators will compare the Propionic acid level among groups
Shannon diversity index
时间窗: At enrollment
the investigators will compare alpha diversity and community similarity among groups by using the Shannon diversity index.
Simpson index
时间窗: At enrollment
the investigators will compare alpha diversity and community similarity among groups by using the Simpson index.
Principal component analysis
时间窗: At enrollment
the investigators will compare beta diversity and community similarity among groups by using the principal component analysis.
Peripheral blood mononuclear cells level
时间窗: At enrollment
the investigators will compare the Peripheral blood mononuclear cells level among groups
Valeric acid level
时间窗: At enrollment
the investigators will compare the valeric acid level among groups
Microbiome composition by metagenomic analysis
时间窗: At enrollment
The composition of microbiome will be presented as bar graph.
Isobutyric acid level
时间窗: At enrollment
the investigators will compare the Isobutyric acid level among groups
Isovaleric acid level
时间窗: At enrollment
the investigators will compare the Isovaleric acid level among groups
secondary bile acid level
时间窗: At enrollment
the investigators will compare the secondary bile acid level among groups
Acetic acid level
时间窗: At enrollment
the investigators will compare the acetic acid level among groups
Butyric acid level
时间窗: At enrollment
the investigators will compare the butyric acid level among groups
dimethylglycine level
时间窗: At enrollment
the investigators will compare the dimethylglycine level among groups
次要结局
- Difference of metabolome according to Exacerbation(within 1 year after enrollment)
- Difference of microbiome according to Exacerbation(within 1 year after enrollment)
- Difference of microbiome according to death(within 1 year after enrollment)
- Difference of metabolome according to death(within 1 year after enrollment)
研究者
Sei Won Lee
Professor
Asan Medical Center