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

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ClinicalTrials.gov Identifier: NCT03755505
Recruitment Status : Recruiting
First Posted : November 28, 2018
Last Update Posted : November 28, 2018
Sponsor:
Information provided by (Responsible Party):
Sei Won Lee, 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.

Condition or disease Intervention/treatment
Pulmonary Disease, Chronic Obstructive Emphysema or COPD Microbiota Diagnostic Test: obtain samples from sputum, feces and urine

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 60 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Year
Official Title: The Microbiome of Sputum, Urine and Feces in Healthy Persons and Chronic Obstructive Pulmonary Disease (COPD) Patients
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Healthy Smoker
Healthy smoker with normal spirometry value
Diagnostic Test: obtain samples from sputum, feces and urine
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)
Diagnostic Test: obtain samples from sputum, feces and urine
Samples are obtained from participants. No further intervention is required. Obtained samples will be further analyzed.




Primary Outcome Measures :
  1. Alpha diversity measured by operational taxonomic unit (OTU) quantitative analysis [ Time Frame: 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%.

  2. Microbiome composition by metagenomic analysis [ Time Frame: An average of 1 month ]
    The composition of microbiome is presented as bar graph.


Secondary Outcome Measures :
  1. Biodiversity described by the Shannon diversity index and the Simpson index [ Time Frame: An average of 1 month ]
    The Shannon index and the Simpson index is calculated by using metagenomic data.

  2. Biodiversity described by Principal Component Analysis (PCA) [ Time Frame: An average of 1 month ]
    PCA is performed for all 16S rRNA gene reads clustered at a 97% similarity.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

COPD group

- Same as above

Healthy smokers

  • Participants with smoking history
  • Participants with normal spirometry results
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03755505


Contacts
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Contact: Sei Won Lee, M.D. Ph.D. 82-2-3010-3990 iseiwon@gmail.com

Locations
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Korea, Republic of
Asan Medical Center, University of Ulsan College of Medicine Recruiting
Seoul, Songpa, Korea, Republic of, 05505
Contact: Sei Won Lee, MD PhD    +82-2-3010-3990    iseiwon@gmail.com   
Sponsors and Collaborators
Asan Medical Center

Additional Information:

Publications:
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Responsible Party: Sei Won Lee, Clinical Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT03755505     History of Changes
Other Study ID Numbers: 2018-0980
First Posted: November 28, 2018    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sei Won Lee, Asan Medical Center:
Emphysema
Microbiome

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Emphysema
Pulmonary Emphysema
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes