Skip to content

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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03755505
Acronym
COPD
Enrollment
60
Registered
2018-11-28
Start date
2018-12-01
Completion date
2019-09-30
Last updated
2018-11-28

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

Conditions

Emphysema or COPD, Microbiota, Pulmonary Disease, Chronic Obstructive

Keywords

Emphysema, Microbiome

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.

Interventions

DIAGNOSTIC_TESTobtain samples from sputum, feces and urine

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
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
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) * Patients with recent (8 weeks prior to screening) exacerbation or other respiratory illness

Design outcomes

Primary

MeasureTime frameDescription
Alpha diversity measured by operational taxonomic unit (OTU) quantitative analysisAn average of 1 monthDNA 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 monthThe composition of microbiome is presented as bar graph.

Secondary

MeasureTime frameDescription
Biodiversity described by the Shannon diversity index and the Simpson indexAn average of 1 monthThe Shannon index and the Simpson index is calculated by using metagenomic data.
Biodiversity described by Principal Component Analysis (PCA)An average of 1 monthPCA 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