Gastroesophageal Reflux Disease (GERD)NCT01389401
Salivary Epidermal Growth Factor (EGF) Concentration Before and After Treatment of Reflux Laryngitis
An observational study of Gastroesophageal Reflux Disease (GERD) and Chronic Laryngitis, run by Faculdade de Ciências Médicas da Santa Casa de São Paulo at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 72 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroesophageal Reflux Disease (GERD), Chronic Laryngitis
- What is being tested?
- omeprazole
- How many people
- 36 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2009to Jul 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 72 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 25 adults with reflux laryngitis 13 healthy controls
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Otolaryngology Department of Santa Casa School of Medicine and Hospitals of São Paulo Brazil
São Paulo, São Paulo, 01222-000
About this study
Official title: 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
Read the 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.
- Being tested
- omeprazole
- Keywords
- Larynx, GERD, saliva, epidermal growth factor
- Medical subject headings
- Gastroesophageal Reflux, Laryngeal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omeprazoleDrug
Also called reflux group pre-treatment, reflux group post-treatment, control group
omeprazole 40 mg twice a day for 16 weeks; dietary and lifestyle changes
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: omeprazole | |
| control group | healthy controls paired by gender and age that do not present symptoms and videolaryngoscopic signs suggestive of reflux laryngitis Receives: Drug: omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study startJan 2009
- Primary completionJan 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux Disease (GERD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculdade de Ciências Médicas da Santa Casa de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CLAUDIA ALESSANDRA ECKLEY, Faculdade de Ciências Médicas da Santa Casa de São Paulo
- Investigators
- CLAUDIA A ECKLEY, MD, Principal investigator, Assistant Professor Otolaryngology Department Santa Casa School of Medicine and Hospitals of São Paulo Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01389401
- Sponsor's protocol ID
- cescsp179/04
- Status last verified
- Mar 2013
- First submitted
- 6 Jul 2011
- Last updated
- 6 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15467608Sarosiek 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.
PubMed 7556968Rourk 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.
PubMed 8304310Eckley 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.
PubMed 17589721
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salivary Epidermal Growth Factor (EGF) Concentration Before and After Treatment of Reflux Laryngitis: Final Results
- ClinicalTrials.gov ID
- NCT01389401
- Acronym / sponsor ID
- cescsp179/04
- Keywords
- Larynx, GERD, saliva, epidermal growth factor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Faculdade de Ciências Médicas da Santa Casa de São PauloUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 8 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| reflux laryngitis group pre-treatment | – | Drug: omeprazoleadults 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. |
| study group - post treatment | – | Drug: omeprazoleadults 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 |
| control group | – | Drug: omeprazolehealthy controls paired by gender and age that do not present symptoms and videolaryngoscopic signs suggestive of reflux laryngitis |
Who may qualify
- Ages
- 19 to 72 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 25 adults with reflux laryngitis 13 healthy controls
Key inclusion criteria (6 listed)
- study group:
- control group:
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| omeprazoleAlso: reflux group pre-treatment, reflux group post-treatment, control groupomeprazole 40 mg twice a day for 16 weeks; dietary and lifestyle changes | Drug | control group, reflux laryngitis group pre-treatment, study group - post treatment |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2013.
- Background: PubMed 15467608Eckley 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.
- Background: PubMed 7556968Sarosiek 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.
- Background: PubMed 8304310Rourk 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.
- Results publication: PubMed 17589721Eckley 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CLAUDIA A ECKLEY, MD principal investigator
Assistant Professor Otolaryngology Department Santa Casa School of Medicine and Hospitals of São Paulo Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux Disease (GERD) and Chronic Laryngitis, run by Faculdade de Ciências Médicas da Santa Casa de São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
salivary EGF concentration (time frame: 120 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01389401, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2013.