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

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):

Study Description
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

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

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

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

Biospecimen Description:
BAL broncho alveolar lavage at bronchoscopy

Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: October 26, 2012    Key Record Dates
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