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

NCT03904758 | Completed

• 1 other identifier: FNO-ENT-Pepsin
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Extraesophageal Reflux

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  24 hours

Secondary Outcomes (1)

• Presence of pepsin in the saliva

  24 hours

Study Arms (2)

Monitoring of pH with Restech

EXPERIMENTAL

The patients with EER randomized into this arm will undergo pH monitoring using Restech system

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

Diagnostic Test: Pepsin in saliva test

Interventions

Pepsin in saliva test DIAGNOSTIC_TEST

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

Monitoring of oesophageal impedance; Monitoring of pH with Restech

Eligibility Criteria

• Age: 15 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- suspicion of EER indicated for diagnostics

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

Location

MeSH Terms

Conditions

Laryngopharyngeal Reflux

Condition Hierarchy (Ancestors)

Gastroesophageal Reflux; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Laryngeal Diseases; Respiratory Tract Diseases

Study Officials

• Martin Formánek, MD,PhD

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking will be used in the study.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The patients will be randomized into two study arms.

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: April 5, 2019
• Study Start: March 1, 2019
• Primary Completion: November 30, 2021
• Study Completion: December 31, 2021
• Last Updated: December 7, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)