Analysis of the Microbiome in the Healthy Smokers and COPD Patients

Asan Medical Center60 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pulmonary Disease, Chronic Obstructive Microbiota

Interventions

Obtain samples from sputum and fecesDIAGNOSTIC_TEST

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Department of Pulmonary and Critical Care Medicine and Clinical Research Center for Chronic Obstructive Airway Diseases, Asan Medical Center, University of Ulsan College of Medicine

Seoul, South Korea

Outcomes

Primary Outcomes

Alpha diversity measured by operational taxonomic unit (OTU) quantitative analysis

DNA is extracted from each sample from each patient by using a DNA Isolation Kit. The 16S universal primers are used for amplification of 16S ribosomal ribonucleic acid (rRNA) genes with polymerase chain reaction (PCR) system. After amplication, sequencing is performed using the GREENGENES database, after which a metagenomic analysis was performed by the MD Healthcare corporation using MDx-Pro software (Ver.1, Seoul, South Korea). Taxonomic assignment of these sequences is carried out with an operational taxonomic unit (OTU) cutoff of 3%.

Time frame: An average of 3 months

Microbiome composition by metagenomic analysis

The composition of microbiome is presented as bar graph.

Time frame: An average of 3 months

Secondary Outcomes

Biodiversity described by the Shannon diversity index and the Simpson index

The Shannon index and the Simpson index is calculated by using metagenomic data.

Time frame: An average of 3 months

Biodiversity described by Principal Component Analysis (PCA)

PCA is performed for all 16S rRNA gene reads clustered at a 97% similarity.

Time frame: An average of 3 months

Central Contacts

Sei Won Lee, M.D. Ph.D.

CONTACT

82-2-3010-3990 iseiwon@gmail.com

Data from ClinicalTrials.gov

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