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Extraesophageal Reflux - Feasibility of Measurement of Pepsin in Saliva as a Diagnostic Option

Extraesophageal Reflux - Feasibility of Measurement of Pepsin in Saliva as a Diagnostic Option

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03904758
Enrollment
50
Registered
2019-04-05
Start date
2019-03-01
Completion date
2021-12-31
Last updated
2022-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extraesophageal Reflux

Keywords

extraesophageal reflux, laryngopharyngeal reflux, pepsin, saliva, oropharyngeal pH monitoring, esophageal impedance

Brief 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.

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.

Interventions

DIAGNOSTIC_TESTPepsin in saliva test

The presence of pepsin in the saliva will be tested in both groups of patients.

Sponsors

University Hospital Ostrava
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Masking description

No masking will be used in the study.

Intervention model description

The patients will be randomized into two study arms.

Eligibility

Sex/Gender
ALL
Age
15 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Reflux symptom index (RSI)24 hoursReflux 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)24 hoursReflux finding score is a standard tool for assessing the presence and severity of reflex, evaluating reflux symptoms in eight areas.

Secondary

MeasureTime frameDescription
Presence of pepsin in the saliva24 hoursThe presence of pepsin in the saliva will be assessed.

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026