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

Not yet recruiting

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT06101459
• Lead Sponsor: Asan Medical Center

Brief Summary

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?

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-19
• Study First Submitted QC: 2023-10-24
• Last Update Submitted: 2023-10-24
• Study First Posted: 2023-10-26
• Last Update Posted: 2023-10-26
• Study Start: 2023-12-01
• Primary Completion: 2028-06-30
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Difference of metabolome according to Exacerbation	within 1 year after enrollment	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
Difference of microbiome according to Exacerbation	within 1 year after enrollment	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
Difference of microbiome according to death	within 1 year after enrollment	the investigators will investigate the baseline difference of microbiome between COPD patients with death and COPD patients without death
Difference of metabolome according to death	within 1 year after enrollment	the investigators will investigate the baseline difference of metabolome between COPD patients with death and COPD patients without death