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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01389401
Enrollment
36
Registered
2011-07-08
Start date
2009-01-31
Completion date
2011-07-31
Last updated
2013-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Laryngitis, Gastroesophageal Reflux Disease (GERD)

Keywords

Larynx, GERD, saliva, epidermal growth factor

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

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.

Interventions

DRUGomeprazole

omeprazole 40 mg twice a day for 16 weeks; dietary and lifestyle changes

Sponsors

Faculdade de Ciências Médicas da Santa Casa de São Paulo
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to 72 Years
Healthy volunteers
Yes

Inclusion criteria

* study group: * symptoms of reflux laryngitis (Reflux Symptom Index- RSI \>13) and videolaryngoscopic signs (Reflux Finding Score - RFS \>7), * positive 24 hour double probe esophageal PH monitoring; * control group: * Reflux Symptom Index (RSI)\<13 * Reflux Finding Score (RFS) \< 7

Exclusion criteria

* tobacco, alcohol or other inhaled drug use; * chronic or acute rhinosinusitis; * prior history of surgery to the digestive tract or salivary glands; * prior or current diagnosis of head and neck or digestive tract tumors; * chronic use of drugs known to alter salivary flow and irritate the larynx, such as, diuretics, anticonvulsants, antihistamines, and inhaled steroids

Design outcomes

Primary

MeasureTime frameDescription
salivary EGF concentration120 dayssalivary Epidermal Growth Factor (EGF) concentrations were determined with commercially available ELISA kit from whole saliva sampled before and after treatment in study group and in healthy controls

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026