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Analysis of the Microbiome in the Healthy Smokers and COPD Patients

Analysis of the Microbiome in the Healthy Smokers and COPD Patients

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04336423
Enrollment
60
Registered
2020-04-07
Start date
2020-04-06
Completion date
2023-12-31
Last updated
2020-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microbiota, Pulmonary Disease, Chronic Obstructive

Keywords

Chronic obstructive pulmonary disease, Microbiome

Brief summary

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.

Detailed 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.

Interventions

DIAGNOSTIC_TESTObtain samples from sputum and feces

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

Sponsors

Asan Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Alpha diversity measured by operational taxonomic unit (OTU) quantitative analysisAn average of 3 monthsDNA 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 3 monthsThe composition of microbiome is presented as bar graph.

Secondary

MeasureTime frameDescription
Biodiversity described by the Shannon diversity index and the Simpson indexAn average of 3 monthsThe Shannon index and the Simpson index is calculated by using metagenomic data.
Biodiversity described by Principal Component Analysis (PCA)An average of 3 monthsPCA is performed for all 16S rRNA gene reads clustered at a 97% similarity.

Countries

South Korea

Contacts

Primary ContactSei Won Lee, M.D. Ph.D.
iseiwon@gmail.com82-2-3010-3990

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026