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

Sponsor

Asan Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06101459

Collaborator

Seoul National University College of Medicine (Other), HEM Pharma Inc. (Industry)

300

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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?

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Jun 30, 2028

Anticipated Study Completion Date :

Dec 31, 2028

Arms and Interventions

Arm	Intervention/Treatment
COPD patient with significant smoking history 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 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 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

Outcome Measures

Primary Outcome Measures

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.
Microbiome composition by metagenomic analysis [At enrollment]
The composition of microbiome will be presented as bar graph.
Peripheral blood mononuclear cells level [At enrollment]
the investigators will compare the Peripheral blood mononuclear cells level among groups
Acetic acid level [At enrollment]
the investigators will compare the acetic acid level among groups
Propionic acid level [At enrollment]
the investigators will compare the Propionic acid level among groups
Isobutyric acid level [At enrollment]
the investigators will compare the Isobutyric acid level among groups
Butyric acid level [At enrollment]
the investigators will compare the butyric acid level among groups
Isovaleric acid level [At enrollment]
the investigators will compare the Isovaleric acid level among groups
Valeric acid level [At enrollment]
the investigators will compare the valeric acid level among groups
dimethylglycine level [At enrollment]
the investigators will compare the dimethylglycine level among groups
secondary bile acid level [At enrollment]
the investigators will compare the secondary bile acid level among groups

Secondary Outcome Measures

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 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 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Asan Medical Center
Seoul National University College of Medicine
HEM Pharma Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sei Won Lee, Professor, Asan Medical Center

ClinicalTrials.gov Identifier:

NCT06101459

Other Study ID Numbers:

2023-1049

First Posted:

Oct 26, 2023

Last Update Posted:

Oct 26, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Sei Won Lee, Professor, Asan Medical Center

Microbiome

Metabolome

Smoking history

Additional relevant MeSH terms:

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Oct 26, 2023