A Study About Association Between Microbiome, Metabolome and Clinical Characteristics in COPD Patients

Study Overview
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Brief Summary
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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?

Official Title
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A Study About Association Between Microbiome, Metabolome and Clinical Characteristics in COPD Patients

Conditions
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Chronic Obstructive Pulmonary Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Withdrawal of informed consent History of acute exacerbation or antibiotics use within 3 months Difficulty to collect adequate stool, sputum and blood samples
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COPD patient with significant smoking history<br>Patients with following conditions smoking history more than 30 pack*year FEV1/FVC ratio <0.7 No acute exacerbation history within 3 months | |
| COPD patient without significant smoking history<br>Patients with following conditions smoking history less than 0.5 pack*year FEV1/FVC ratio <0.7 No acute exacerbation history within 3 months | |
| Healthy smoker<br>Patients with following conditions smoking history more than 30 pack*year FEV1/FVC ratio ≥0.7 No current use of medication for any chronic respiratory disease | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shannon diversity index | the investigators will compare alpha diversity and community similarity among groups by using the Shannon diversity index. | At enrollment | 
| Simpson index | the investigators will compare alpha diversity and community similarity among groups by using the Simpson index. | At enrollment | 
| Principal component analysis | the investigators will compare beta diversity and community similarity among groups by using the principal component analysis. | At enrollment | 
| Microbiome composition by metagenomic analysis | The composition of microbiome will be presented as bar graph. | At enrollment | 
| Peripheral blood mononuclear cells level | the investigators will compare the Peripheral blood mononuclear cells level among groups | At enrollment | 
| Acetic acid level | the investigators will compare the acetic acid level among groups | At enrollment | 
| Propionic acid level | the investigators will compare the Propionic acid level among groups | At enrollment | 
| Isobutyric acid level | the investigators will compare the Isobutyric acid level among groups | At enrollment | 
| Butyric acid level | the investigators will compare the butyric acid level among groups | At enrollment | 
| Isovaleric acid level | the investigators will compare the Isovaleric acid level among groups | At enrollment | 
| Valeric acid level | the investigators will compare the valeric acid level among groups | At enrollment | 
| dimethylglycine level | the investigators will compare the dimethylglycine level among groups | At enrollment | 
| secondary bile acid level | the investigators will compare the secondary bile acid level among groups | At enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of microbiome according to Exacerbation | the investigators will investigate the baseline difference of microbiome between COPD patients with moderate to severe exacerbation and COPD patients without moderate to severe exacerbation | within 1 year after enrollment | 
| Difference of metabolome according to Exacerbation | the investigators will investigate the baseline difference of metabolome between COPD patients with moderate to severe exacerbation and COPD patients without moderate to severe exacerbation | within 1 year after enrollment | 
| Difference of microbiome according to death | the investigators will investigate the baseline difference of microbiome between COPD patients with death and COPD patients without death | within 1 year after enrollment | 
| Difference of metabolome according to death | the investigators will investigate the baseline difference of metabolome between COPD patients with death and COPD patients without death | within 1 year after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microbiome, Metabolome, Smoking history