<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03755505</url>
  </required_header>
  <id_info>
    <org_study_id>2018-0980</org_study_id>
    <nct_id>NCT03755505</nct_id>
  </id_info>
  <brief_title>The Microbiome of Sputum, Urine and Feces in Healthy Persons and Chronic Obstructive Pulmonary Disease (COPD) Patients</brief_title>
  <acronym>COPD</acronym>
  <official_title>The Microbiome of Sputum, Urine and Feces in Healthy Persons and Chronic Obstructive Pulmonary Disease (COPD) Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Asan Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Asan Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Extensive studies suggest composition of microbiome of respiratory samples or lung tissues in&#xD;
      COPD patients is different from the composition of healthy smokers. Aim of this study is to&#xD;
      analyze composition of microbiome of various samples (e.g. feces, sputum, and urine) and to&#xD;
      describe difference of composition between COPD patients and healthy smokers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After the introduction of the Gut-Lung axis theory, extensive studies revealed diversity of&#xD;
      microbiomes among healthy smokers and COPD patients form the respiratory samples or lung&#xD;
      tissues. In the previous study, distinct difference in composition of microbiome in lung&#xD;
      tissue between healthy smokers and COPD patients was reported. This is a cross sectional&#xD;
      study to analyze composition of microbiome of various samples (e.g. feces, sputum, and urine)&#xD;
      and to compare difference of composition between COPD patients and healthy smokers. This&#xD;
      study would help establishing gut-lung axis model in humans.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">December 1, 2018</start_date>
  <completion_date type="Anticipated">September 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Alpha diversity measured by operational taxonomic unit (OTU) quantitative analysis</measure>
    <time_frame>An average of 1 month</time_frame>
    <description>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%.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Microbiome composition by metagenomic analysis</measure>
    <time_frame>An average of 1 month</time_frame>
    <description>The composition of microbiome is presented as bar graph.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Biodiversity described by the Shannon diversity index and the Simpson index</measure>
    <time_frame>An average of 1 month</time_frame>
    <description>The Shannon index and the Simpson index is calculated by using metagenomic data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biodiversity described by Principal Component Analysis (PCA)</measure>
    <time_frame>An average of 1 month</time_frame>
    <description>PCA is performed for all 16S rRNA gene reads clustered at a 97% similarity.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Pulmonary Disease, Chronic Obstructive</condition>
  <condition>Emphysema or COPD</condition>
  <condition>Microbiota</condition>
  <arm_group>
    <arm_group_label>Healthy Smoker</arm_group_label>
    <description>Healthy smoker with normal spirometry value</description>
  </arm_group>
  <arm_group>
    <arm_group_label>COPD</arm_group_label>
    <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) &lt;0.7)</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>obtain samples from sputum, feces and urine</intervention_name>
    <description>Samples are obtained from participants. No further intervention is required. Obtained samples will be further analyzed.</description>
    <arm_group_label>COPD</arm_group_label>
    <arm_group_label>Healthy Smoker</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        COPD group&#xD;
&#xD;
        - Same as above&#xD;
&#xD;
        Healthy smokers&#xD;
&#xD;
          -  Participants with smoking history&#xD;
&#xD;
          -  Participants with normal spirometry results&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with smoking history at least 10 pack-year&#xD;
&#xD;
          -  Patients with persistent airflow limitation that was not fully reversible (e.g.&#xD;
             post-bronchodilator forced expiratory volume in 1 second/forced vital capacity (&#xD;
             FEV1/FVC) &lt;0.7)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with co-existing illness that would interfere with study results (e.g.,&#xD;
             malignancy, congestive heart failure, cerebrovascular disorders, chronic renal&#xD;
             failure, diabetes with severe complications, or uncontrolled hypertension)&#xD;
&#xD;
          -  Patients with respiratory disease other than obstructive lung disease (e.g., previous&#xD;
             pulmonary resection, tuberculosis-destroyed lung, and bronchiectasis)&#xD;
&#xD;
          -  Patients with recent (8 weeks prior to screening) exacerbation or other respiratory&#xD;
             illness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Sei Won Lee, M.D. Ph.D.</last_name>
    <phone>82-2-3010-3990</phone>
    <email>iseiwon@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Asan Medical Center, University of Ulsan College of Medicine</name>
      <address>
        <city>Seoul</city>
        <state>Songpa</state>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sei Won Lee, MD PhD</last_name>
      <phone>+82-2-3010-3990</phone>
      <email>iseiwon@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>28408748</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>26595731</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>23071781</PMID>
  </reference>
  <reference>
    <citation>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 &quot;healthy&quot; smoker and in COPD. PLoS One. 2011 Feb 22;6(2):e16384. doi: 10.1371/journal.pone.0016384.</citation>
    <PMID>21364979</PMID>
  </reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>November 26, 2018</last_update_submitted>
  <last_update_submitted_qc>November 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Asan Medical Center</investigator_affiliation>
    <investigator_full_name>Sei Won Lee</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Emphysema</keyword>
  <keyword>Microbiome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
    <mesh_term>Pulmonary Emphysema</mesh_term>
    <mesh_term>Emphysema</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03755505
org study id: 2018-0980
nct id: NCT03755505
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Other
time perspective: Cross-Sectional
measure: Alpha diversity measured by operational taxonomic unit (OTU) quantitative analysis
time frame: An average of 1 month
description: 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%.
measure: Microbiome composition by metagenomic analysis
time frame: An average of 1 month
description: The composition of microbiome is presented as bar graph.
measure: Biodiversity described by the Shannon diversity index and the Simpson index
time frame: An average of 1 month
description: The Shannon index and the Simpson index is calculated by using metagenomic data.
measure: Biodiversity described by Principal Component Analysis (PCA)
time frame: An average of 1 month
description: PCA is performed for all 16S rRNA gene reads clustered at a 97% similarity.
arm group label: Healthy Smoker
description: Healthy smoker with normal spirometry value
arm group label: 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)
intervention type: Diagnostic Test
intervention name: obtain samples from sputum, feces and urine
description: Samples are obtained from participants. No further intervention is required. Obtained samples will be further analyzed.
arm group label: COPD
arm group label: Healthy Smoker
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sei Won Lee, M.D. Ph.D.
phone: 82-2-3010-3990
email: iseiwon@gmail.com
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
citation: 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.
PMID: 28408748
citation: 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.
PMID: 26595731
citation: 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.
PMID: 23071781
citation: 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.
PMID: 21364979
responsible party type: Principal Investigator
investigator affiliation: Asan Medical Center
investigator full name: Sei Won Lee
investigator title: Clinical Professor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Pulmonary Emphysema
mesh term: Emphysema
sharing ipd: No