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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06101459
Enrollment
300
Registered
2023-10-26
Start date
2023-12-01
Completion date
2028-12-31
Last updated
2023-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Microbiome, Metabolome, Smoking history

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?

Interventions

None listed

Sponsors

Seoul National University College of Medicine
CollaboratorUNKNOWN
HEM Pharma Inc.
CollaboratorINDUSTRY
Asan Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
secondary bile acid levelAt enrollmentthe investigators will compare the secondary bile acid level among groups
Butyric acid levelAt enrollmentthe investigators will compare the butyric acid level among groups
Isovaleric acid levelAt enrollmentthe investigators will compare the Isovaleric acid level among groups
Valeric acid levelAt enrollmentthe investigators will compare the valeric acid level among groups
dimethylglycine levelAt enrollmentthe investigators will compare the dimethylglycine level among groups
Shannon diversity indexAt enrollmentthe investigators will compare alpha diversity and community similarity among groups by using the Shannon diversity index.
Simpson indexAt enrollmentthe investigators will compare alpha diversity and community similarity among groups by using the Simpson index.
Principal component analysisAt enrollmentthe investigators will compare beta diversity and community similarity among groups by using the principal component analysis.
Microbiome composition by metagenomic analysisAt enrollmentThe composition of microbiome will be presented as bar graph.
Peripheral blood mononuclear cells levelAt enrollmentthe investigators will compare the Peripheral blood mononuclear cells level among groups
Acetic acid levelAt enrollmentthe investigators will compare the acetic acid level among groups
Propionic acid levelAt enrollmentthe investigators will compare the Propionic acid level among groups
Isobutyric acid levelAt enrollmentthe investigators will compare the Isobutyric acid level among groups

Secondary

MeasureTime frameDescription
Difference of metabolome according to Exacerbationwithin 1 year after enrollmentthe 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 deathwithin 1 year after enrollmentthe investigators will investigate the baseline difference of microbiome between COPD patients with death and COPD patients without death
Difference of metabolome according to deathwithin 1 year after enrollmentthe investigators will investigate the baseline difference of metabolome between COPD patients with death and COPD patients without death
Difference of microbiome according to Exacerbationwithin 1 year after enrollmentthe investigators will investigate the baseline difference of microbiome between COPD patients with moderate to severe exacerbation and COPD patients without moderate to severe exacerbation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026