Extraesophageal Reflux - Feasibility of Measurement of Pepsin in Saliva as a Diagnostic Option (NCT03904758) | Clinical Trial Compass
CompletedNot Applicable
Extraesophageal Reflux - Feasibility of Measurement of Pepsin in Saliva as a Diagnostic Option
Czechia50 participantsStarted 2019-03-01
Plain-language 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. 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.
Who can participate
Age range
15 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
\- suspicion of EER indicated for diagnostics
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.