Analysis of the Microbiome in the Healthy Smokers and COPD Patients

Asan Medical Center

Status: Unknown

Conditions: Pulmonary Disease, Chronic Obstructive; Microbiota

Treatments: Diagnostic Test: Obtain samples from sputum and feces

Study type: Observational

Funder types: Other

Identifiers

NCT04336423

Microbiome cohort

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

60 participants in 2 patient groups

Healthy smoker

Description:

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

Treatment:

Diagnostic Test: Obtain samples from sputum and feces

COPD patient

Description:

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)

Treatment:

Diagnostic Test: Obtain samples from sputum and feces