GERD Clinical Trial - Salivary Epidermal Growth Factor (EGF) Concentration

Status Completed

Clinical Trial 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

Clinical Trial 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01389401
Study type	Observational
Source	Faculdade de Ciências Médicas da Santa Casa de São Paulo
Contact
Status	Completed
Phase	N/A
Start date	January 2009
Completion date	July 2011

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms