NCT01389401

Salivary Epidermal Growth Factor (EGF) Concentration Before and After Treatment of Reflux Laryngitis

Salivary Epidermal Growth Factor (EGF) Concentration Before and After Treatment of Reflux Laryngitis: Final Results

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 36 (actual)
• Sponsor: Faculdade de Ciências Médicas da Santa Casa de São Paulo · Academic / Other
• Sex: All
• Age: 19 Years – 72 Years
• Healthy volunteers: Accepted

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

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.

Conditions

• Gastroesophageal Reflux Disease (GERD)
• Chronic Laryngitis

Interventions

Type	Name	Description
DRUG	omeprazole	omeprazole 40 mg twice a day for 16 weeks; dietary and lifestyle changes

Timeline

• Start date: 2009-01-01
• Primary completion: 2011-01-01
• Completion: 2011-07-01
• First posted: 2011-07-08
• Last updated: 2013-03-06

Locations

1 site across 1 country: Brazil