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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2012 by Sheba Medical Center.
Recruitment status was:  Not yet recruiting
ClinicalTrials.gov Identifier:
First Posted: October 26, 2012
Last Update Posted: October 26, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sheba Medical Center
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 Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Pepsin Levels in the Broncho-Alveolar-Lavage Fluid of Patients With Idiopathic Pulmonary Fibrosis

Resource links provided by NLM:

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • BAL Pepsin level [ Time Frame: 18 MONTHS ]

Biospecimen Description:
BAL broncho alveolar lavage at bronchoscopy

Estimated Enrollment: 40
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
IPF patients diagnosed according to clinical and radiological findings
Other interstitial lung diseases such as sarcoidosis or hypersensitivity pneumonitis diagnosed as per clinical and radiological findings


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with IPF versus patients with other interstitial lung disorders (non IPF)

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01714934

Sheba Medical Center
Ramat Gan, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
  More Information

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01714934     History of Changes
Other Study ID Numbers: SHEBA-12-9440-TS-CTIL
First Submitted: October 23, 2012
First Posted: October 26, 2012
Last Update Posted: October 26, 2012
Last Verified: October 2012

Keywords provided by Sheba Medical Center:

Additional relevant MeSH terms:
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial