The Microbiome of Sputum, Urine and Feces in Healthy Persons and Chronic Obstructive Pulmonary Disease (COPD) Patients

Asan Medical Center60 enrolled

Overview

Extensive studies suggest composition of microbiome of respiratory samples or lung tissues in COPD patients is different from the composition of healthy smokers. Aim of this study is to analyze composition of microbiome of various samples (e.g. feces, sputum, and urine) and to describe difference of composition between COPD patients and healthy smokers.

After the introduction of the Gut-Lung axis theory, extensive studies revealed 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 is a cross sectional study to analyze composition of microbiome of various samples (e.g. feces, sputum, and urine) and to compare difference of composition between COPD patients and healthy smokers. This study would help establishing gut-lung axis model in humans.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pulmonary Disease, Chronic Obstructive Emphysema or COPD Microbiota

Interventions

obtain samples from sputum, feces and urineDIAGNOSTIC_TEST

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

Eligibility

Sex: ALLHealthy 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) * Patients with recent (8 weeks prior to screening) exacerbation or other respiratory illness

Locations (1)

Asan Medical Center, University of Ulsan College of Medicine

Seoul, Songpa, South Korea

RECRUITING

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 1 month

Microbiome composition by metagenomic analysis

The composition of microbiome is presented as bar graph.

Time frame: An average of 1 month

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 1 month

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 1 month

Central Contacts

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

CONTACT

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.