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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
IDIOPATHIC PULMONARY FIBROSIS

Study Design

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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

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

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

Biospecimen Description:

BAL broncho alveolar lavage at bronchoscopy

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Israel
Sheba Medical Center
Ramat Gan, Israel, 52621

Sponsors and Collaborators

Sheba Medical Center

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Sheba Medical Center
ClinicalTrials.gov Identifier:	NCT01714934 History of Changes
Other Study ID Numbers:	SHEBA-12-9440-TS-CTIL
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