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

IDIOPATHIC PULMONARY FIBROSIS Clinical Trial

Official title:

Study of Pepsin Levels in the Broncho-Alveolar-Lavage Fluid of Patients With Idiopathic Pulmonary Fibrosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01714934
• Other study ID #: SHEBA-12-9440-TS-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: October 23, 2012
• Last updated: October 25, 2012
• Start date: January 2013
• Est. completion date: December 2014

Study information

• Verified date: October 2012
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BAL Pepsin level		18 MONTHS	No