<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/NCT01714934</url>
  </required_header>
  <id_info>
    <org_study_id>SHEBA-12-9440-TS-CTIL</org_study_id>
    <nct_id>NCT01714934</nct_id>
  </id_info>
  <brief_title>The Role of Gastric Content Microaspirations in the Pathogenesis of Idiopathic Pulmonary Fibrosis</brief_title>
  <official_title>Study of Pepsin Levels in the Broncho-Alveolar-Lavage Fluid of Patients With Idiopathic Pulmonary Fibrosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheba Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sheba Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The pathogenesis of idiopathic pulmonary fibrosis (IPF) is debatable. Looking for an insult&#xD;
      to lung parenchyma that generates the pathogenesis of the disease is challenging. Pepsin is a&#xD;
      proteolytic enzyme present in the gastric juice. Microaspirations of gastric content were&#xD;
      described as a potential factor for injury in many chronic lung disorders. Bronchoalveolar&#xD;
      lavage (BAL) is a routine investigation technique in interstitial lung diseases. The presence&#xD;
      of pepsin in the BAL fluid recovered from patients with IPF may indicate a possible role for&#xD;
      gastric microaspirations in the pathogenesis of the disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2013</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">June 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>BAL Pepsin level</measure>
    <time_frame>18 MONTHS</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">40</enrollment>
  <condition>IDIOPATHIC PULMONARY FIBROSIS</condition>
  <arm_group>
    <arm_group_label>IPF</arm_group_label>
    <description>IPF patients diagnosed according to clinical and radiological findings</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NON IPF</arm_group_label>
    <description>Other interstitial lung diseases such as sarcoidosis or hypersensitivity pneumonitis diagnosed as per clinical and radiological findings</description>
  </arm_group>
  <biospec_descr>
    <textblock>
      BAL broncho alveolar lavage at bronchoscopy&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with IPF versus patients with other interstitial lung disorders (non IPF)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with interstitial lung disorders including IPF&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients younger than 18 years or older than 85,&#xD;
&#xD;
          -  pregnant women,&#xD;
&#xD;
          -  patients that present with medical conditions contra -indicated for performing&#xD;
             bronchoscopy including sedation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sheba Medical Center</name>
      <address>
        <city>Ramat Gan</city>
        <zip>52621</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 23, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <last_update_submitted>October 25, 2012</last_update_submitted>
  <last_update_submitted_qc>October 25, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 26, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>IDIOPATHIC PULMONARY FIBROSIS</keyword>
  <keyword>MICROASPIRATION</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Fibrosis</mesh_term>
    <mesh_term>Idiopathic Pulmonary Fibrosis</mesh_term>
    <mesh_term>Fibrosis</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/NCT01714934
org study id: SHEBA-12-9440-TS-CTIL
nct id: NCT01714934
lead sponsor: 
has dmc: No
The pathogenesis of idiopathic pulmonary fibrosis (IPF) is debatable. Looking for an insult
      to lung parenchyma that generates the pathogenesis of the disease is challenging. Pepsin is a
      proteolytic enzyme present in the gastric juice. Microaspirations of gastric content were
      described as a potential factor for injury in many chronic lung disorders. Bronchoalveolar
      lavage (BAL) is a routine investigation technique in interstitial lung diseases. The presence
      of pepsin in the BAL fluid recovered from patients with IPF may indicate a possible role for
      gastric microaspirations in the pathogenesis of the disease.
observational model: Cohort
time perspective: Prospective
measure: BAL Pepsin level
time frame: 18 MONTHS
arm group label: IPF
description: IPF patients diagnosed according to clinical and radiological findings
arm group label: NON IPF
description: Other interstitial lung diseases such as sarcoidosis or hypersensitivity pneumonitis diagnosed as per clinical and radiological findings
BAL broncho alveolar lavage at bronchoscopy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Pulmonary Fibrosis
mesh term: Idiopathic Pulmonary Fibrosis
mesh term: Fibrosis