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

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. Identifier: NCT01714934
Recruitment Status : Unknown
Verified October 2012 by Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : October 26, 2012
Last Update Posted : October 26, 2012
Information provided by (Responsible Party):
Sheba Medical Center

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

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Study Type : Observational
Estimated 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 : January 2013
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : December 2014

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

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

Biospecimen Description:
BAL broncho alveolar lavage at bronchoscopy

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
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

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 identifier (NCT number): NCT01714934

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

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Responsible Party: Sheba Medical Center Identifier: NCT01714934     History of Changes
Other Study ID Numbers: SHEBA-12-9440-TS-CTIL
First Posted: October 26, 2012    Key Record Dates
Last Update Posted: October 26, 2012
Last Verified: October 2012
Keywords provided by Sheba Medical Center:
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial