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

NCT ID: NCT03755505

Last Updated: 2018-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-01

Study Completion Date

2019-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Disease, Chronic Obstructive Emphysema or COPD Microbiota

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Healthy Smoker

Healthy smoker with normal spirometry value

obtain samples from sputum, feces and urine

Intervention Type DIAGNOSTIC_TEST

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

COPD

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)

obtain samples from sputum, feces and urine

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

obtain samples from sputum, feces and urine

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sei Won Lee

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Asan Medical Center, University of Ulsan College of Medicine

Seoul, Songpa, South Korea

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

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

Role: CONTACT

82-2-3010-3990

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sei Won Lee, MD PhD

Role: primary

+82-2-3010-3990

References

Explore related publications, articles, or registry entries linked to this study.

Kim HJ, Kim YS, Kim KH, Choi JP, Kim YK, Yun S, Sharma L, Dela Cruz CS, Lee JS, Oh YM, Lee SD, Lee SW. The microbiome of the lung and its extracellular vesicles in nonsmokers, healthy smokers and COPD patients. Exp Mol Med. 2017 Apr 14;49(4):e316. doi: 10.1038/emm.2017.7.

Reference Type BACKGROUND
PMID: 28408748 (View on PubMed)

Marsland BJ, Trompette A, Gollwitzer ES. The Gut-Lung Axis in Respiratory Disease. Ann Am Thorac Soc. 2015 Nov;12 Suppl 2:S150-6. doi: 10.1513/AnnalsATS.201503-133AW.

Reference Type BACKGROUND
PMID: 26595731 (View on PubMed)

Pragman AA, Kim HB, Reilly CS, Wendt C, Isaacson RE. The lung microbiome in moderate and severe chronic obstructive pulmonary disease. PLoS One. 2012;7(10):e47305. doi: 10.1371/journal.pone.0047305. Epub 2012 Oct 11.

Reference Type BACKGROUND
PMID: 23071781 (View on PubMed)

Erb-Downward JR, Thompson DL, Han MK, Freeman CM, McCloskey L, Schmidt LA, Young VB, Toews GB, Curtis JL, Sundaram B, Martinez FJ, Huffnagle GB. Analysis of the lung microbiome in the "healthy" smoker and in COPD. PLoS One. 2011 Feb 22;6(2):e16384. doi: 10.1371/journal.pone.0016384.

Reference Type BACKGROUND
PMID: 21364979 (View on PubMed)

Lee SH, Kim J, Kim NH, Kim OH, Shon CH, Kim SJ, Jang Y, Yun S, Lim SE, Jung SY, Yoo HJ, Heo SH, Lee SW. Gut microbiota composition and metabolite profiling in smokers: a comparative study between emphysema and asymptomatic individuals with therapeutic implications. Thorax. 2023 Nov;78(11):1080-1089. doi: 10.1136/thorax-2021-217923. Epub 2023 Jul 26.

Reference Type DERIVED
PMID: 37495367 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2018-0980

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Michigan Early Disease Progression Cohort
NCT04968249 ACTIVE_NOT_RECRUITING