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

NCT01389401 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 36

Last updated 2013-03-06

No results posted yet for this study

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

Conditions

  • Gastroesophageal Reflux Disease (GERD)
  • Chronic Laryngitis

Interventions

DRUG

omeprazole

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

Sponsors & Collaborators

  • Faculdade de Ciências Médicas da Santa Casa de São Paulo

    lead OTHER

Principal Investigators

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

Eligibility

Min Age
19 Years
Max Age
72 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2011-01-31
Completion
2011-07-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01389401 on ClinicalTrials.gov