Analysis of the Microbiome in the Healthy Smokers and COPD Patients

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-06

Study Completion Date

2023-12-31

Brief Summary

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This study is to build a microbiome cohort by collecting sputum and fecal samples every few months for three years from healthy smokers and chronic obstructive pulmonary disease (COPD) patients. The aim of this study is to analyze the composition of microbiome of various samples (e.g. sputum, feces) and describe the difference between healthy smokers and COPD patients.

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Detailed Description

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After the introduction of the gut-lung axis theory, extensive studies revealed the diversity of microbiomes among healthy smokers and COPD patients form the respiratory samples or lung tissues. In the previous study, distinct difference in composition of microbiome in lung tissue between healthy smokers and COPD patients was reported. This study is to build a microbiome cohort by collecting sputum and fecal samples every few months for three years from healthy smokers and chronic obstructive pulmonary disease (COPD) patients who are being followed up by Asan Medical Center. The aim of this study is to analyze the composition of microbiome of various samples (e.g. sputum, feces) and describe the difference between healthy smokers and COPD patients. This study would help establishing gut-lung axis model in humans.

Conditions

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Pulmonary Disease, Chronic Obstructive Microbiota

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy smoker

Healthy smokers with smoking history at least 10 pack-years and normal spirometry value

Obtain samples from sputum and feces

Intervention Type DIAGNOSTIC_TEST

Samples are obtained from participants. No further intervention is required. Obtained samples will be further analyzed.

COPD patient

Patients with smoking history at least 10 pack-years and persistent airflow limitation that was not fully reversible (e.g. post-bronchodilator forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) \<0.7)

Obtain samples from sputum and feces

Intervention Type DIAGNOSTIC_TEST

Samples are obtained from participants. No further intervention is required. Obtained samples will be further analyzed.

Interventions

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Obtain samples from sputum and feces

Samples are obtained from participants. No further intervention is required. Obtained samples will be further analyzed.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients with smoking history at least 10 pack-year
* Patients with persistent airflow limitation that was not fully reversible (e.g. post-bronchodilator forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) \<0.7)

Exclusion Criteria

* Patients with co-existing illness that would interfere with study results (e.g., malignancy, congestive heart failure, cerebrovascular disorders, chronic renal failure, diabetes with severe complications, or uncontrolled hypertension)
* Patients with respiratory disease other than obstructive lung disease (e.g., previous pulmonary resection, tuberculosis-destroyed lung, and bronchiectasis)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Sei Won Lee

Division of Pulmonology and Critical Care Medicine, Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea

Responsibility Role PRINCIPAL_INVESTIGATOR