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

* 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

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Key information

Conditions

Gastroesophageal Reflux Disease (GERD) Chronic Laryngitis Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Laryngeal Diseases Otorhinolaryngologic Diseases Respiratory Tract Diseases

Age range

19 year–72 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Otolaryngology Department of Santa Casa School of Medicine and Hospitals of São Paulo Brazil

São Paulo, 01222-000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omeprazole

Drug

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

Other names: reflux group pre-treatment, reflux group post-treatment, control group

Primary outcomes

salivary EGF concentration

Time frame: 120 days

salivary 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

Sponsors and collaborators

Lead sponsor

Faculdade de Ciências Médicas da Santa Casa de São Paulo

Other

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2011
First posted: Jul 8, 2011
Registry last updated: Mar 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed