Extraesophageal RefluxNCT03904758
Extraesophageal Reflux - Feasibility of Measurement of Pepsin in Saliva as a Diagnostic Option
A study testing Pepsin in saliva test in people with Extraesophageal Reflux, run by University Hospital Ostrava at 1 site in Czechia.
Trial summary
The diagnostics of extraesophageal reflux (EER) is challenging. Currently, 24-h dual-probe esophageal pH monitoring or impedance is considered the best diagnostic method for EER. The 24-h oropharyngeal pH monitoring is a newer method aimed at detecting episodes of reflux to the oropharynx. Read more about this study
- Who is it for?
- Ages 15 to 99 years
- Conditions the study is for
- Extraesophageal Reflux
- What is being tested?
- Pepsin in saliva test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Mar 2019to 31 Dec 2021
- Phase
- Interventional
- 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 15 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- suspicion of EER indicated for diagnostics
Who cannot join
- head and neck cancer
- not-signing of the informed consent with participation in the study
- intolerance of 24-hour monitoring
- treatment with proton pump inhibitors
Trial locations and contacts
1 site in 1 country.
Czechia1 site
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 70852
About this study
The diagnostics of extraesophageal reflux (EER) is challenging. Currently, 24-h dual-probe esophageal pH monitoring or impedance is considered the best diagnostic method for EER. The 24-h oropharyngeal pH monitoring is a newer method aimed at detecting episodes of reflux to the oropharynx. Unfortunately, all these methods have many disadvantages. Pepsin detection in saliva would be an almost ideal diagnostic technique. However, data of its reliability is lacking. The aim of the study is to compare results of oropharyngeal pH monitoring and esophageal impedance monitoring, compared to a quantified pepsin presence in the saliva obtained immediately prior to 24-hour monitoring and to evaluate the feasibility of this technique as a routine option of diagnosing the presence of extraesophageal reflux.
Read the detailed description
Extraesophageal reflux (EER) has recently been found to be a risk factor for many head and neck pathologies. Many studies have shown that contact between the refluxed content and mucous tissue can cause local inflammation and edema and thus facilitate the development of inflammation. Although important, the diagnostics of EER is not easy. The simplest means of collecting information about reflux problems is questioning potential sufferers. However, although many questionnaires have been developed over the last few years, questioning is still not a suitable technique for the evaluation of EER, the reason being that symptoms of EER are heterogeneous and very common. Currently, 24-h dual-probe esophageal pH monitoring or impedance is considered the best diagnostic method for EER. The 24-h oropharyngeal pH monitoring is a newer method aimed at detecting episodes of reflux to the oropharynx and seems to generate similar results. However, these methods may not be tolerated well. Moreover, the position of the sensor, which is placed in the hypopharynx or oropharynx, does not precisely reflect the amount of reflux content that reaches larynx, nasopharynx, nasal cavity or middle ear. Another disadvantage of pH monitoring is that it enables only a short-term analysis over a timespan of just 24-48 h. Detection of pepsin in fluids and tissues is considered by some authors to be perhaps more appropriate than pH monitoring because it reflects the long-term effects of EER and proves that EER is truly affecting the examined region. This is particularly true for more distant regions like the middle ear. Pepsin detection in saliva would be very well tolerated and fast diagnostic method. However, data of its reliability are lacking. The aim of the study is to compare results of oropharyngeal pH monitoring and esophageal impedance monitoring, compared to a quantified pepsin presence in the saliva obtained immediately prior to 24-hour monitoring and to evaluate the feasibility of this diagnostic option as a routine method.
- Conditions
- Extraesophageal Reflux
- Being tested
- Pepsin in saliva test
- Keywords
- extraesophageal reflux, laryngopharyngeal reflux, pepsin, saliva, oropharyngeal pH monitoring, esophageal impedance
- Medical subject headings
- Laryngopharyngeal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pepsin in saliva testDiagnostic test
The presence of pepsin in the saliva will be tested in both groups of patients.
| Study group | Role | What they receive |
|---|---|---|
| Monitoring of pH with Restech | Experimental | The patients with EER randomized into this arm will undergo pH monitoring using Restech system Receives: Diagnostic Test: Pepsin in saliva test |
| Monitoring of oesophageal impedance | Experimental | The patients with EER randomized into this arm will undergo monitoring of oesophageal impedance Receives: Diagnostic Test: Pepsin in saliva test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reflux symptom index (RSI)
Reflux symptom index is a standard tool in the form of a questionnaire scale where the patients evaluate their problems related to reflux on a scale of 0 (no problems) to 5 (severe). The value of RSI over 13 may be indicative of serious reflux-related problems.
Measured: 24 hours
Reflux finding score (RFS)
Reflux finding score is a standard tool for assessing the presence and severity of reflex, evaluating reflux symptoms in eight areas.
Measured: 24 hours
Secondary outcomes (1)
Presence of pepsin in the saliva
The presence of pepsin in the saliva will be assessed.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start1 Mar 2019
- Primary completion30 Nov 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extraesophageal RefluxStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients will be randomized into two study arms.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Formánek, MD,PhD, Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03904758
- Sponsor's protocol ID
- FNO-ENT-Pepsin
- Status last verified
- Dec 2022
- First submitted
- 3 Apr 2019
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators do not plan to share individual participant data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extraesophageal Reflux - Feasibility of Measurement of Pepsin in Saliva as a Diagnostic Option
- ClinicalTrials.gov ID
- NCT03904758
- Acronym / sponsor ID
- FNO-ENT-Pepsin
- Conditions
- Extraesophageal Reflux
- Keywords
- extraesophageal reflux, laryngopharyngeal reflux, pepsin, saliva, oropharyngeal pH monitoring, esophageal impedance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 5 Apr 2019 (actual)
- 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.
The diagnostics of extraesophageal reflux (EER) is challenging. Currently, 24-h dual-probe esophageal pH monitoring or impedance is considered the best diagnostic method for EER. The 24-h oropharyngeal pH monitoring is a newer method aimed at detecting episodes of reflux to the oropharynx. Unfortunately, all these methods have many disadvantages. Pepsin detection in saliva would be an almost ideal diagnostic technique. However, data of its reliability is lacking. The aim of the study is to compare results of oropharyngeal pH monitoring and esophageal impedance monitoring, compared to a quantified pepsin presence in the saliva obtained immediately prior to 24-hour monitoring and to evaluate the feasibility of this technique as a routine option of diagnosing the presence of extraesophageal reflux.
Detailed description
Extraesophageal reflux (EER) has recently been found to be a risk factor for many head and neck pathologies. Many studies have shown that contact between the refluxed content and mucous tissue can cause local inflammation and edema and thus facilitate the development of inflammation. Although important, the diagnostics of EER is not easy. The simplest means of collecting information about reflux problems is questioning potential sufferers. However, although many questionnaires have been developed over the last few years, questioning is still not a suitable technique for the evaluation of EER, the reason being that symptoms of EER are heterogeneous and very common. Currently, 24-h dual-probe esophageal pH monitoring or impedance is considered the best diagnostic method for EER. The 24-h oropharyngeal pH monitoring is a newer method aimed at detecting episodes of reflux to the oropharynx and seems to generate similar results. However, these methods may not be tolerated well. Moreover, the position of the sensor, which is placed in the hypopharynx or oropharynx, does not precisely reflect the amount of reflux content that reaches larynx, nasopharynx, nasal cavity or middle ear. Another disadvantage of pH monitoring is that it enables only a short-term analysis over a timespan of just 24-48 h. Detection of pepsin in fluids and tissues is considered by some authors to be perhaps more appropriate than pH monitoring because it reflects the long-term effects of EER and proves that EER is truly affecting the examined region. This is particularly true for more distant regions like the middle ear. Pepsin detection in saliva would be very well tolerated and fast diagnostic method. However, data of its reliability are lacking. The aim of the study is to compare results of oropharyngeal pH monitoring and esophageal impedance monitoring, compared to a quantified pepsin presence in the saliva obtained immediately prior to 24-hour monitoring and to evaluate the feasibility of this diagnostic option as a routine method.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The patients will be randomized into two study arms.
| Arm | Type | Receives |
|---|---|---|
| Monitoring of pH with Restech | Experimental | Diagnostic Test: Pepsin in saliva testThe patients with EER randomized into this arm will undergo pH monitoring using Restech system |
| Monitoring of oesophageal impedance | Experimental | Diagnostic Test: Pepsin in saliva testThe patients with EER randomized into this arm will undergo monitoring of oesophageal impedance |
Who may qualify
- Ages
- 15 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- suspicion of EER indicated for diagnostics
Key exclusion criteria (4 listed)
- head and neck cancer
- not-signing of the informed consent with participation in the study
- intolerance of 24-hour monitoring
- treatment with proton pump inhibitors
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 |
|---|---|---|
| Pepsin in saliva testThe presence of pepsin in the saliva will be tested in both groups of patients. | Diagnostic test | Monitoring of oesophageal impedance, Monitoring of pH with Restech |
Primary outcome
Reflux symptom index (RSI)
Time frame: 24 hours
Reflux symptom index is a standard tool in the form of a questionnaire scale where the patients evaluate their problems related to reflux on a scale of 0 (no problems) to 5 (severe). The value of RSI over 13 may be indicative of serious reflux-related problems.
Reflux finding score (RFS)
Time frame: 24 hours
Reflux finding score is a standard tool for assessing the presence and severity of reflex, evaluating reflux symptoms in eight areas.
1 secondary outcome
Presence of pepsin in the saliva
Time frame: 24 hours
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 7 Dec 2022.
- Individual participant dataSharing planned: No. The investigators do not plan to share individual participant data with other researchers.
Related trials for Extraesophageal Reflux
Not yet recruiting
Comprehensive Analysis of the Swallowing Mechanism Using High-resolution Manometry With Impedance
Extraesophageal Reflux, Laryngopharyngeal Reflux
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.
Martin Formánek, MD,PhD principal investigator
University Hospital Ostrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pepsin in saliva test in people with Extraesophageal Reflux, run by University Hospital Ostrava at 1 site in Czechia.
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 1 inclusion and 4 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 7 Dec 2022. 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 Czechia. 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?
Reflux symptom index (RSI) (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Dec 2022.