<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/NCT03236480</url>
  </required_header>
  <id_info>
    <org_study_id>2109901</org_study_id>
    <secondary_id>2016YFC0903800</secondary_id>
    <nct_id>NCT03236480</nct_id>
  </id_info>
  <brief_title>The Gut-lung Axis in Chronic Obstructive Pulmonary Disease</brief_title>
  <official_title>Dynamic Changes of the Respiratory Microbiota and Its Relationship to Fecal Microbiota in Chronic Obstructive Pulmonary Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University People's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ningde City Hospital, Fujian, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking University People's Hospital</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>
      Patients with chronic obstructive pulmonary disease (COPD) are 2-3 times more likely to occur&#xD;
      together with chronic gastrointestinal tract (GIT) diseases, such as inflammatory bowel&#xD;
      disease (IBD) or irritable bowel syndrome (IBS). Similarly, despite many patients have no&#xD;
      history of acute or chronic respiratory disease, up to 50% of IBD patients and 33% of IBS&#xD;
      patients have pulmonary involvement, such as inflammation or impaired lung function.&#xD;
      Increasing evidence indicated chronic gut and lung disease share key conceptual features with&#xD;
      the disorder and dysregulation of the microbial ecosystem. However, the underlying mechanisms&#xD;
      are not well understood.&#xD;
&#xD;
      Our study is aimed to elucidate the intimate relationship between the gastrointestinal tract&#xD;
      and respiratory tract, and uncover the mechanisms by which the gut microbiota affects the&#xD;
      immune responses in the lungs, and vice versa.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Anticipated">January 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>all-cause mortality</measure>
    <time_frame>patients will be followed for 3 months after their remission from hospital</time_frame>
    <description>all-cause death after the enrollment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>exacerbations</measure>
    <time_frame>during the 3-month follow-up</time_frame>
    <description>exacerbations of COPD</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Pulmonary Disease, Chronic Obstructive</condition>
  <condition>Microbiota</condition>
  <condition>Immunity, Mucosal</condition>
  <condition>Metabolism</condition>
  <arm_group>
    <arm_group_label>COPD</arm_group_label>
    <description>Patients who admitted to Peking Universtiy People's Hospital and Ningde City Hospital between January 2017 and January 2019 with AECOPD will be enrolled</description>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy control</arm_group_label>
    <description>People aged over 40, without any chronic respiratory disease or acute respiratory infections in the last 2 weeks, and be willing to participate in the study</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      1.Lower respiratory tract specimens including sputum, endotracheal aspiration and&#xD;
      bronchoalveolar lavage fluid. 2.Peripheral whole blood samples 3.fecal samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients admitted to Peking University People's Hospital and Ningde City Hospital with an&#xD;
        exacerbation of COPD between January 2017 and January 2019 will be enrolled.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  admitted to hospital with an exacerbation of COPD;&#xD;
&#xD;
          -  with no history of probiotics taken;&#xD;
&#xD;
          -  the duration of antibiotics treatment before enrollment should be less than 72 hours.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  being immunocompromised, including history of glucocorticoid taken for more than 1&#xD;
             month, history of immunosuppressive therapy, history of human immunodeficiency virus&#xD;
             (HIV) infection, solid tumor or hematological malignancy;&#xD;
&#xD;
          -  history of long-term nursing home stays;&#xD;
&#xD;
          -  history of recently hospitalized (&lt;90 days).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhancheng Gao, Pro.</last_name>
    <role>Study Chair</role>
    <affiliation>Peking University People's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yali Zheng, Dr.</last_name>
    <phone>+8615011451515</phone>
    <email>yali_zheng@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Peking University People's Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100044</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yali Zheng, Dr</last_name>
      <phone>15011451515</phone>
      <phone_ext>86</phone_ext>
      <email>drylzheng@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>July 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <last_update_submitted>July 28, 2017</last_update_submitted>
  <last_update_submitted_qc>July 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03236480
org study id: 2109901
secondary id: 2016YFC0903800
nct id: NCT03236480
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients with chronic obstructive pulmonary disease (COPD) are 2-3 times more likely to occur
      together with chronic gastrointestinal tract (GIT) diseases, such as inflammatory bowel
      disease (IBD) or irritable bowel syndrome (IBS). Similarly, despite many patients have no
      history of acute or chronic respiratory disease, up to 50% of IBD patients and 33% of IBS
      patients have pulmonary involvement, such as inflammation or impaired lung function.
      Increasing evidence indicated chronic gut and lung disease share key conceptual features with
      the disorder and dysregulation of the microbial ecosystem. However, the underlying mechanisms
      are not well understood.

      Our study is aimed to elucidate the intimate relationship between the gastrointestinal tract
      and respiratory tract, and uncover the mechanisms by which the gut microbiota affects the
      immune responses in the lungs, and vice versa.
observational model: Case-Control
time perspective: Prospective
measure: all-cause mortality
time frame: patients will be followed for 3 months after their remission from hospital
description: all-cause death after the enrollment
measure: exacerbations
time frame: during the 3-month follow-up
description: exacerbations of COPD
arm group label: COPD
description: Patients who admitted to Peking Universtiy People's Hospital and Ningde City Hospital between January 2017 and January 2019 with AECOPD will be enrolled
arm group label: healthy control
description: People aged over 40, without any chronic respiratory disease or acute respiratory infections in the last 2 weeks, and be willing to participate in the study
1.Lower respiratory tract specimens including sputum, endotracheal aspiration and
      bronchoalveolar lavage fluid. 2.Peripheral whole blood samples 3.fecal samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Zhancheng Gao, Pro.
role: Study Chair
affiliation: Peking University People's Hospital
last name: Yali Zheng, Dr.
phone: +8615011451515
email: yali_zheng@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: Undecided