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

Sponsor:

ClinicalTrials.gov Identifier:

NCT01714934

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

Purpose

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
IDIOPATHIC PULMONARY FIBROSIS


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:

Genetics Home Reference related topics: idiopathic pulmonary fibrosis

MedlinePlus related topics: Pulmonary Fibrosis

Genetic and Rare Diseases Information Center resources: Idiopathic Pulmonary Fibrosis

U.S. FDA Resources

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)

Groups/Cohorts
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

Eligibility

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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)

Criteria

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

Locations


Israel
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:


IDIOPATHIC PULMONARY FIBROSIS MICROASPIRATION

Additional relevant MeSH terms:


Fibrosis Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis Idiopathic Interstitial Pneumonias	Pathologic Processes Lung Diseases Respiratory Tract Diseases Lung Diseases, Interstitial

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