A Study About Association Between Microbiome, Metabolome and Clinical Characteristics in COPD Patients
NCT ID: NCT06101459
Last Updated: 2023-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
300 participants
OBSERVATIONAL
2023-12-01
2028-12-31
Brief Summary
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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?
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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COPD patient with significant smoking history
Patients with following conditions
1. smoking history more than 30 pack\*year
2. FEV1/FVC ratio \<0.7
3. No acute exacerbation history within 3 months
No interventions assigned to this group
COPD patient without significant smoking history
Patients with following conditions
1. smoking history less than 0.5 pack\*year
2. FEV1/FVC ratio \<0.7
3. No acute exacerbation history within 3 months
No interventions assigned to this group
Healthy smoker
Patients with following conditions
1. smoking history more than 30 pack\*year
2. FEV1/FVC ratio ≥0.7
3. No current use of medication for any chronic respiratory disease
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* History of acute exacerbation or antibiotics use within 3 months
* Difficulty to collect adequate stool, sputum and blood samples
ALL
Yes
Sponsors
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Seoul National University College of Medicine
UNKNOWN
HEM Pharma Inc.
INDUSTRY
Asan Medical Center
OTHER
Responsible Party
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Sei Won Lee
Professor
Other Identifiers
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2023-1049
Identifier Type: -
Identifier Source: org_study_id
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