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

NCT03904758 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-12-07

No results posted yet for this study

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.

Conditions

  • Extraesophageal Reflux

Interventions

DIAGNOSTIC_TEST

Pepsin in saliva test

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

Sponsors & Collaborators

  • University Hospital Ostrava

    lead OTHER

Principal Investigators

  • Martin Formánek, MD,PhD · University Hospital Ostrava

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2021-11-30
Completion
2021-12-31

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03904758 on ClinicalTrials.gov