The Microbiome of Sputum, Urine and Feces in Healthy Persons and Chronic Obstructive Pulmonary Disease (COPD) Patients
- Conditions
- Pulmonary Disease, Chronic ObstructiveMicrobiotaEmphysema 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
- 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)
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Healthy Smoker obtain samples from sputum, feces and urine Healthy smoker with normal spirometry value COPD obtain samples from sputum, feces and urine 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)
- Primary Outcome Measures
Name Time Method Alpha diversity measured by operational taxonomic unit (OTU) quantitative analysis An 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 analysis An average of 1 month The composition of microbiome is presented as bar graph.
- Secondary Outcome Measures
Name Time Method Biodiversity described by the Shannon diversity index and the Simpson index An 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