An interventional study of Pepsin in saliva test in Extraesophageal Reflux, sponsored by University Hospital Ostrava. Completed at 1 site in Czechia. Open to participants aged 15 Years to 99 Years. Per ClinicalTrials.gov, last updated 2022-12-07.
Sponsored by University Hospital Ostrava · Not applicable, Interventional, and Diagnostic
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.
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.
1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.
This study's enrollment of 50 is below the median of 72 across 712 interventional studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →University Hospital Ostrava is the lead sponsor of 146 studies on the registry; 50 are open to participants now.
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Exclusion Criteria:
The patients with EER randomized into this arm will undergo pH monitoring using Restech system
Diagnostic Test: Pepsin in saliva test
The patients with EER randomized into this arm will undergo monitoring of oesophageal impedance
Diagnostic Test: Pepsin in saliva test
The presence of pepsin in the saliva will be tested in both groups of patients.
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.
Time frame: 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.
Time frame: 24 hours
Presence of pepsin in the saliva
The presence of pepsin in the saliva will be assessed.
Time frame: 24 hours
Plan to share: No — The investigators do not plan to share individual participant data with other researchers.
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This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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University Hospital Ostrava