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
Recruitment status was Not yet recruiting
Sponsor:
Sheba Medical Center
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
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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
pulmonary alveolar microlithiasis
MedlinePlus related topics:
Pulmonary Fibrosis
Genetic and Rare Diseases Information Center resources:
Anorchia
Idiopathic Pulmonary Fibrosis
Rothmund Thomson Syndrome
Usual Interstitial Pneumonia
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 |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01714934
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
No publications provided
| 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 Idiopathic Pulmonary Fibrosis Pulmonary Fibrosis Idiopathic Interstitial Pneumonias |
Lung Diseases Lung Diseases, Interstitial Pathologic Processes Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on March 03, 2015