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

October 25, 2012 updated by: Sheba Medical Center

Study of Pepsin Levels in the Broncho-Alveolar-Lavage Fluid of Patients With Idiopathic Pulmonary Fibrosis

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ramat Gan, Israel, 52621
        • Sheba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with IPF versus patients with other interstitial lung disorders (non IPF)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
BAL Pepsin level
Time Frame: 18 MONTHS
18 MONTHS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ANTICIPATED)

June 1, 2014

Study Completion (ANTICIPATED)

December 1, 2014

Study Registration Dates

First Submitted

October 23, 2012

First Submitted That Met QC Criteria

October 25, 2012

First Posted (ESTIMATE)

October 26, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

October 26, 2012

Last Update Submitted That Met QC Criteria

October 25, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-12-9440-TS-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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