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

March 5, 2013 updated by: CLAUDIA ALESSANDRA ECKLEY, Faculdade de Ciências Médicas da Santa Casa de São Paulo

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

  • 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 01222-000
        • Otolaryngology Department of Santa Casa School of Medicine and Hospitals of São Paulo Brazil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 72 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

25 adults with reflux laryngitis 13 healthy controls

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
reflux laryngitis group pre-treatment
adults with clinical suspicion of Reflux Laryngitis confirmed by 24-hour double probe esophageal monitoring who have not made use of any treatment in the past 15 days.
Drug: omeprazole
omeprazole 40 mg twice a day for 16 weeks; dietary and lifestyle changes
Other Names:
  • control group
  • reflux group pre-treatment
  • reflux group post-treatment
study group - post treatment
adults with reflux laryngitis after 16 weeks of treatment with proton pump inhibitor (omeprazole 40 mg twice a day)and dietary/lifestyle changes that present improvement in symptoms and video laryngoscopic signs of chronic laryngitis
Drug: omeprazole
omeprazole 40 mg twice a day for 16 weeks; dietary and lifestyle changes
Other Names:
  • control group
  • reflux group pre-treatment
  • reflux group post-treatment
control group
healthy controls paired by gender and age that do not present symptoms and videolaryngoscopic signs suggestive of reflux laryngitis
Drug: omeprazole
omeprazole 40 mg twice a day for 16 weeks; dietary and lifestyle changes
Other Names:
  • control group
  • reflux group pre-treatment
  • reflux group post-treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
120 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Faculdade de Ciências Médicas da Santa Casa de São Paulo

Investigators

  • Principal Investigator: CLAUDIA A ECKLEY, MD, Assistant Professor Otolaryngology Department Santa Casa School of Medicine and Hospitals of São Paulo Brazil

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

July 6, 2011

First Submitted That Met QC Criteria

July 7, 2011

First Posted (Estimate)

July 8, 2011

Study Record Updates

Last Update Posted (Estimate)

March 6, 2013

Last Update Submitted That Met QC Criteria

March 5, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • cescsp179/04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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