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

A

Asan Medical Center

Status

Unknown

Conditions

Pulmonary Disease, Chronic Obstructive
Emphysema or COPD
Microbiota

Treatments

Diagnostic Test: obtain samples from sputum, feces and urine

Study type

Observational

Funder types

Other

Identifiers

NCT03755505
2018-0980

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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

Trial design

60 participants in 2 patient groups

Healthy Smoker
Description:
Healthy smoker with normal spirometry value
Treatment:
Diagnostic Test: obtain samples from sputum, feces and urine
COPD
Description:
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)
Treatment:
Diagnostic Test: obtain samples from sputum, feces and urine

Trial contacts and locations

1

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Central trial contact

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

Data sourced from clinicaltrials.gov

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