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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06101459
Other study ID # 2023-1049
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 1, 2023
Est. completion date December 31, 2028

Study information

Verified date October 2023
Source Asan Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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?


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date December 31, 2028
Est. primary completion date June 30, 2028
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Asan Medical Center HEM Pharma Inc., Seoul National University College of Medicine

Outcome

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