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

Conditions
Pulmonary Disease, Chronic Obstructive
Microbiota
Emphysema or COPD
Interventions
Diagnostic Test: obtain samples from sputum, feces and urine
Registration Number
NCT03755505
Lead Sponsor
Asan Medical Center
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
60
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)
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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
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Healthy Smokerobtain samples from sputum, feces and urineHealthy smoker with normal spirometry value
COPDobtain samples from sputum, feces and urinePatients 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)
Primary Outcome Measures
NameTimeMethod
Alpha diversity measured by operational taxonomic unit (OTU) quantitative analysisAn average of 1 month

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%.

Microbiome composition by metagenomic analysisAn average of 1 month

The composition of microbiome is presented as bar graph.

Secondary Outcome Measures
NameTimeMethod
Biodiversity described by the Shannon diversity index and the Simpson indexAn average of 1 month

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

Biodiversity described by Principal Component Analysis (PCA)An average of 1 month

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

Trial Locations

Locations (1)

Asan Medical Center, University of Ulsan College of Medicine

🇰🇷

Seoul, Songpa, Korea, Republic of

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