Ignite Creation Date:
2024-05-05 @ 11:40 PM
Last Modification Date:
2024-10-26 @ 10:37 AM
Study NCT ID:
NCT01389401
Status:
COMPLETED
Last Update Posted:
2013-03-06
First Post:
2011-07-06
Brief Title:
Salivary Epidermal Growth Factor EGF Concentration Before and After Treatment of Reflux Laryngitis
Sponsor:
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Organization:
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Study Overview
Official Title:
Salivary Epidermal Growth Factor EGF Concentration Before and After Treatment of Reflux Laryngitis Final Results
Status:
COMPLETED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Saliva plays a key role in the homeostasis of the digestive tract
The reflux of gastroesophageal contents may cause damage to the esophageal laryngeal and pharyngeal mucosas
There seems to be no correlation between the severity of reflux episodes and the intensity of inflammatory changes suggesting individual protective mechanisms to refluxate exposure
Inorganic and Organic Salivary changes have been associated to Gastroesophageal Reflux Disease GERD and its supraesophageal manifestations especially reflux laryngitis Laryngopharyngeal Reflux- LPR
Decreased salivary Epidermal Growth factor EGF concentrations have been found in patients with GERD and LPR but it is unclear if these are primary or secondary to the disease
Hypothesis The decreased salivary EGF concentrations in patients with reflux laryngitis is primary and therefore would not change after treatment and control of the disease
The reflux of gastroesophageal contents may cause damage to the esophageal laryngeal and pharyngeal mucosas
There seems to be no correlation between the severity of reflux episodes and the intensity of inflammatory changes suggesting individual protective mechanisms to refluxate exposure
Inorganic and Organic Salivary changes have been associated to Gastroesophageal Reflux Disease GERD and its supraesophageal manifestations especially reflux laryngitis Laryngopharyngeal Reflux- LPR
Decreased salivary Epidermal Growth factor EGF concentrations have been found in patients with GERD and LPR but it is unclear if these are primary or secondary to the disease
Hypothesis The decreased salivary EGF concentrations in patients with reflux laryngitis is primary and therefore would not change after treatment and control of the disease
Detailed Description:
Background Aims Gastroesophageal Reflux Disease GERD is known to affect the upper airways and may cause a variety of inflammatory changes in the pharynx and larynx The pathophysiology of the supraesophageal forms of GERD is widely unknown Studies have suggested decreased salivary epidermal growth factor EGF concentrations in patients with reflux esophagitis and laryngitis It is however unclear if these abnormalities are primary or secondary The aim of the current cohort study was to compare salivary EGF concentrations in adults with reflux laryngitis before and after treatment and control of the disease to that of healthy individuals Methods Twenty-one patients with reflux laryngitis were studied prospectively at a tertiary teaching hospital Spontaneous whole saliva was sampled before and after a 16-week course of full dose proton pump inhibitor PPI twice daily and compared to that of 13 healthy controls Salivary EGF concentrations were established using a commercially available Elisa kit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None