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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 because the information has not been verified recently.
Verified October 2012 by Sheba Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01714934
First received: October 23, 2012
Last updated: October 25, 2012
Last verified: October 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • BAL Pepsin level [ Time Frame: 18 MONTHS ] [ Designated as safety issue: No ]

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
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: October 23, 2012
Last Updated: October 25, 2012
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on September 23, 2016