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

NCT01389401 | Completed

• 1 other identifier: cescsp179/04
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

Gastroesophageal Reflux Disease (GERD); Chronic Laryngitis

Keywords

Larynx; GERD; saliva; epidermal growth factor

Outcome Measures

Primary Outcomes (1)

• salivary EGF concentration

  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

Study Arms (3)

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

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

control group

healthy controls paired by gender and age that do not present symptoms and videolaryngoscopic signs suggestive of reflux laryngitis

Drug: omeprazole

Interventions

omeprazole DRUG

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

Also known as: reflux group pre-treatment, reflux group post-treatment, control group

control group; reflux laryngitis group pre-treatment; study group - post treatment

Eligibility Criteria

• Age: 19 Years - 72 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

25 adults with reflux laryngitis 13 healthy controls

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Faculdade de Ciências Médicas da Santa Casa de São Paulo: lead

Study Sites (1)

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

São Paulo, São Paulo, 01222-000, Brazil

Location

Related Publications (4)

• Eckley CA, Michelsohn N, Rizzo LV, Tadokoro CE, Costa HO. Salivary epidermal growth factor concentration in adults with reflux laryngitis. Otolaryngol Head Neck Surg. 2004 Oct;131(4):401-6. doi: 10.1016/j.otohns.2004.01.020.

  PMID: 15467608 BACKGROUND

• Sarosiek J, McCallum RW. Do salivary organic components play a protective role in health and disease of the esophageal mucosa? Digestion. 1995;56 Suppl 1:32-7. doi: 10.1159/000201299.

  PMID: 7556968 BACKGROUND

• Rourk RM, Namiot Z, Sarosiek J, Yu Z, McCallum RW. Impairment of salivary epidermal growth factor secretory response to esophageal mechanical and chemical stimulation in patients with reflux esophagitis. Am J Gastroenterol. 1994 Feb;89(2):237-44.

  PMID: 8304310 BACKGROUND

• Eckley CA, Rios Lda S, Rizzo LV. Salivary egf concentration in adults with reflux chronic laryngitis before and after treatment: preliminary results. Braz J Otorhinolaryngol. 2007 Mar-Apr;73(2):156-60. doi: 10.1016/s1808-8694(15)31060-0.

  PMID: 17589721 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole saliva

MeSH Terms

Conditions

Gastroesophageal Reflux; Laryngeal Diseases

Interventions

Omeprazole; Control Groups

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• CLAUDIA A ECKLEY, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Claudia A. Eckley, MD

Study Record Dates

• First Submitted: July 6, 2011
• First Posted: July 8, 2011
• Study Start: January 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: July 1, 2011
• Last Updated: March 6, 2013

Record last verified: 2013-03

Locations

BR (1)