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The Role of Gastric Content Microaspirations in the Pathogenesis of Idiopathic Pulmonary Fibrosis

Sponsor
Sheba Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT01714934
Collaborator
(none)
40
Enrollment
1
Location
23
Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Study of Pepsin Levels in the Broncho-Alveolar-Lavage Fluid of Patients With Idiopathic Pulmonary Fibrosis
    Study Start Date :
    Jan 1, 2013
    Anticipated Primary Completion Date :
    Jun 1, 2014
    Anticipated Study Completion Date :
    Dec 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    IPF

    IPF patients diagnosed according to clinical and radiological findings
    NON IPF

    Other interstitial lung diseases such as sarcoidosis or hypersensitivity pneumonitis diagnosed as per clinical and radiological findings

    Outcome Measures

    Primary Outcome Measures

    1. BAL Pepsin level [18 MONTHS]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • patients with interstitial lung disorders including IPF
    Exclusion Criteria:

    • patients younger than 18 years or older than 85,

    • pregnant women,

    • patients that present with medical conditions contra -indicated for performing bronchoscopy including sedation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sheba Medical Center Ramat Gan Israel 52621

    Sponsors and Collaborators

    • Sheba Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sheba Medical Center
    ClinicalTrials.gov Identifier:
    NCT01714934
    Other Study ID Numbers:
    • SHEBA-12-9440-TS-CTIL
    First Posted:
    Oct 26, 2012
    Last Update Posted:
    Oct 26, 2012
    Last Verified:
    Oct 1, 2012
    Keywords provided by Sheba Medical Center
    IDIOPATHIC PULMONARY FIBROSIS
    MICROASPIRATION
    Additional relevant MeSH terms:
    Pulmonary Fibrosis
    Idiopathic Pulmonary Fibrosis
    Fibrosis

    Study Results

    No Results Posted as of Oct 26, 2012