<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/NCT04490447</url>
  </required_header>
  <id_info>
    <org_study_id>20190403</org_study_id>
    <nct_id>NCT04490447</nct_id>
  </id_info>
  <brief_title>Identification of Microbiome and Metabolome of Bronchiectasis in Chinese Population.</brief_title>
  <official_title>Identification of Microbiome and Metabolome of Bronchiectasis in Chinese Population and Role of the &quot;Gut-lung Axis&quot; in Chronic Respiratory Infection With Pseudomonas Aeruginosa.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Pulmonary Hospital, Shanghai, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Pulmonary Hospital, Shanghai, China</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>
      This study aims to investigate the characteristics of gut microbiome and metabolome in non-CF&#xD;
      bronchiectasis patients, hoping to explore the underlying mechanisms as well as the influence&#xD;
      of gut microbiota composition on bronchiectasis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Non-cystic fibrosis bronchiectasis is a chronic airway disease characterized by irreversible&#xD;
      and progressive dilation of the large airways, bronchi and bronchioles, which severely&#xD;
      impairs the life quality of patients and increases the social and economic burden. It is also&#xD;
      a heterogenous disease affected by multiple factors such as geography and ethnicity. The&#xD;
      incidence of bronchiectasis among the Chinese population is about 1.2%, which has clearly&#xD;
      been underestimated. However, due to the lack of awareness, the research of bronchiectasis in&#xD;
      China is still in its infancy. Colonization and recurrent infection of pathogen is the&#xD;
      primary unsolved problem in clinical practice. With the proposition of &quot;gut-lung axis&quot;&#xD;
      theory, the role of gut microbiota in the pathogenesis of respiratory diseases has been&#xD;
      gradually revealed. Evidences have shown that gut microbiota regulates respiratory immunity&#xD;
      via releasing soluble bacterial components and its metabolites into the circulation, as well&#xD;
      as facilitating the migration of immune cells directly to the lung. In the 1980s, a patient&#xD;
      after a colectomy has been reported to generate bronchiectasis. The most common clinical&#xD;
      manifestation of pulmonary involved IBD patients is also bronchiectasis, suggesting that the&#xD;
      &quot;gut-lung axis&quot; may be involved in the pathogenesis of bronchiectasis. Therefore, clarifying&#xD;
      the role and mechanism of gut microbiota in bronchiectasis and its gut microbiome is expected&#xD;
      to provide new theoretical basis and ideas for its diagnosis and treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 1, 2019</start_date>
  <completion_date type="Anticipated">September 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 22, 2021</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>Gut microbiome and metabolomics of bronchiectasis patients and healthy control.</measure>
    <time_frame>12 months</time_frame>
    <description>The microbiome and metabolome results of gut in bronchiectasis patients will be defined from the stool samples using 16S rRNA Miseq sequencing and nontargeted LC-MS-based metabolomics approach.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lung microbiome of bronchiectasis patient.</measure>
    <time_frame>12 months</time_frame>
    <description>The bronchoalveolar lavage fluid (BALF) specimens will be obtained from admitted patients undergoing bronchoscopy and the lung microbiome of bronchiectasis patients will be defined from the BALF samples using 16S rRNA Miseq sequencing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BSI (Bronchiectasis Severity Index) score</measure>
    <time_frame>2 months</time_frame>
    <description>Assessment of the non-cystic fibrosis bronchiectasis severity according to the BSI score at the time of enrollment.&#xD;
BSI score: scale of 0-26, is calculated from the results of age, BMI(body mass index), FEV1% predicted, exacerbations, hospital admissions, airway organisms colonisation, radiological severity etc.) 0-4, 5-8, &gt;9 were separately defined as mild, moderate, severe bronchiectasis, higher score indicates probable higher mortality rate and hospitalisation rate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lung function</measure>
    <time_frame>12 months</time_frame>
    <description>Lung function will be accessed by Pulmonary Function Tests (PFT) and the parameters including FVC ( forced vital capacity), FEV1 (forced the first second of expiratory volume), FEV1% predicted, FEV1/FVC will be documented at the time of enrollment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sputum bacteriological evaluation.</measure>
    <time_frame>12 months</time_frame>
    <description>Sputum bacteriological (pseudomonas aeruginosa and other organisms) will be evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chest high-resolution computed tomography (CT).</measure>
    <time_frame>12 months</time_frame>
    <description>Chest high-resolution computed tomography (CT) results in the recent 6 months will be documented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute exacerbation</measure>
    <time_frame>12 months</time_frame>
    <description>The time of acute exacerbation in the following year will be recorded according to medical information.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalization</measure>
    <time_frame>12 months</time_frame>
    <description>The time of hospitalization in the following year will be recorded according to medical information.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration to the first exacerbation during the one-year follow up.</measure>
    <time_frame>24 months</time_frame>
    <description>The duration to the first exacerbation within one year after the sample collection.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Bronchiectasis</condition>
  <arm_group>
    <arm_group_label>Bronchiectasis</arm_group_label>
    <description>Patient meets diagnose of bronchiectasis refering to &quot;BTS guideline 2010&quot; will be included.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy control</arm_group_label>
    <description>Healthy volunteers will be included.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      faecal samples for 16S rRNA sequencing and LC-MS analysis.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients enrolled in this study should meet the diagnositc criteria of BTS guideline 2010&quot;&#xD;
        . Patients with a history of antibiotic use were admitted to the study. Healthy volunteers&#xD;
        were eligible for inclusion provided they had not received antibiotics within the previous&#xD;
        one month.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
          -  Regular bowel movement: every 2 days - 3 times/ day&#xD;
&#xD;
          -  The diagnose of bronchiectasis should refer to &quot;BTS guideline 2010&quot;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of ABPA&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  Active smoking or alcohol using within last 6 months&#xD;
&#xD;
          -  HIV infection&#xD;
&#xD;
          -  Previous abdominal or rectal surgery&#xD;
&#xD;
          -  Diagnosis of chronic gastrointestinal disease, heart disease, diabetes, severe renal&#xD;
             insufficiency (GFR &lt; 30ml/min) or immunodeficiency&#xD;
&#xD;
          -  Regular use of the following types of medications (&gt; 2 times per week) within last 2&#xD;
             months: opium, loperamide antidiarrheal, systemic antihistaminic, metoclopramide,&#xD;
             proton pump inhibitor&#xD;
&#xD;
          -  Poor compliance or inability to cooperate as judged by the doctor&#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_official>
    <last_name>Jin-fu Xu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Pulmonary Hospital, Shanghai, China</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jin-fu Xu, MD</last_name>
    <phone>+86 13321922898</phone>
    <email>jfxucn@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Shanghai Pulmonary Hospital , Tongji University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kai-xing Ai</last_name>
      <phone>+86-021-65115006</phone>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>April 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>February 18, 2021</last_update_submitted>
  <last_update_submitted_qc>February 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Pulmonary Hospital, Shanghai, China</investigator_affiliation>
    <investigator_full_name>Jin-Fu Xu</investigator_full_name>
    <investigator_title>Director, Head of respiratory medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bronchiectasis</mesh_term>
  </condition_browse>
  <!-- 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/NCT04490447
org study id: 20190403
nct id: NCT04490447
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to investigate the characteristics of gut microbiome and metabolome in non-CF
      bronchiectasis patients, hoping to explore the underlying mechanisms as well as the influence
      of gut microbiota composition on bronchiectasis.
Non-cystic fibrosis bronchiectasis is a chronic airway disease characterized by irreversible
      and progressive dilation of the large airways, bronchi and bronchioles, which severely
      impairs the life quality of patients and increases the social and economic burden. It is also
      a heterogenous disease affected by multiple factors such as geography and ethnicity. The
      incidence of bronchiectasis among the Chinese population is about 1.2%, which has clearly
      been underestimated. However, due to the lack of awareness, the research of bronchiectasis in
      China is still in its infancy. Colonization and recurrent infection of pathogen is the
      primary unsolved problem in clinical practice. With the proposition of "gut-lung axis"
      theory, the role of gut microbiota in the pathogenesis of respiratory diseases has been
      gradually revealed. Evidences have shown that gut microbiota regulates respiratory immunity
      via releasing soluble bacterial components and its metabolites into the circulation, as well
      as facilitating the migration of immune cells directly to the lung. In the 1980s, a patient
      after a colectomy has been reported to generate bronchiectasis. The most common clinical
      manifestation of pulmonary involved IBD patients is also bronchiectasis, suggesting that the
      "gut-lung axis" may be involved in the pathogenesis of bronchiectasis. Therefore, clarifying
      the role and mechanism of gut microbiota in bronchiectasis and its gut microbiome is expected
      to provide new theoretical basis and ideas for its diagnosis and treatment.
observational model: Case-Control
time perspective: Prospective
measure: Gut microbiome and metabolomics of bronchiectasis patients and healthy control.
time frame: 12 months
description: The microbiome and metabolome results of gut in bronchiectasis patients will be defined from the stool samples using 16S rRNA Miseq sequencing and nontargeted LC-MS-based metabolomics approach.
measure: Lung microbiome of bronchiectasis patient.
time frame: 12 months
description: The bronchoalveolar lavage fluid (BALF) specimens will be obtained from admitted patients undergoing bronchoscopy and the lung microbiome of bronchiectasis patients will be defined from the BALF samples using 16S rRNA Miseq sequencing.
measure: BSI (Bronchiectasis Severity Index) score
time frame: 2 months
description: Assessment of the non-cystic fibrosis bronchiectasis severity according to the BSI score at the time of enrollment.
BSI score: scale of 0-26, is calculated from the results of age, BMI(body mass index), FEV1% predicted, exacerbations, hospital admissions, airway organisms colonisation, radiological severity etc.) 0-4, 5-8, >9 were separately defined as mild, moderate, severe bronchiectasis, higher score indicates probable higher mortality rate and hospitalisation rate.
measure: Lung function
time frame: 12 months
description: Lung function will be accessed by Pulmonary Function Tests (PFT) and the parameters including FVC ( forced vital capacity), FEV1 (forced the first second of expiratory volume), FEV1% predicted, FEV1/FVC will be documented at the time of enrollment
measure: Sputum bacteriological evaluation.
time frame: 12 months
description: Sputum bacteriological (pseudomonas aeruginosa and other organisms) will be evaluated.
measure: Chest high-resolution computed tomography (CT).
time frame: 12 months
description: Chest high-resolution computed tomography (CT) results in the recent 6 months will be documented.
measure: Acute exacerbation
time frame: 12 months
description: The time of acute exacerbation in the following year will be recorded according to medical information.
measure: Hospitalization
time frame: 12 months
description: The time of hospitalization in the following year will be recorded according to medical information.
measure: Duration to the first exacerbation during the one-year follow up.
time frame: 24 months
description: The duration to the first exacerbation within one year after the sample collection.
arm group label: Bronchiectasis
description: Patient meets diagnose of bronchiectasis refering to "BTS guideline 2010" will be included.
arm group label: Healthy control
description: Healthy volunteers will be included.
faecal samples for 16S rRNA sequencing and LC-MS analysis.
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: Jin-fu Xu, MD
role: Principal Investigator
affiliation: Shanghai Pulmonary Hospital, Shanghai, China
last name: Jin-fu Xu, MD
phone: +86 13321922898
email: jfxucn@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shanghai Pulmonary Hospital, Shanghai, China
investigator full name: Jin-Fu Xu
investigator title: Director, Head of respiratory medicine
mesh term: Bronchiectasis