Extraesophageal Reflux - Feasibility of Measurement of Pepsin in Saliva as a Diagnostic Option
Primary Purpose
Extraesophageal Reflux
Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Pepsin in saliva test
Sponsored by
About this trial
This is an interventional diagnostic trial for Extraesophageal Reflux focused on measuring extraesophageal reflux, laryngopharyngeal reflux, pepsin, saliva, oropharyngeal pH monitoring, esophageal impedance
Eligibility Criteria
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
Sites / Locations
- University Hospital Ostrava
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Monitoring of pH with Restech
Monitoring of oesophageal impedance
Arm Description
The patients with EER randomized into this arm will undergo pH monitoring using Restech system
The patients with EER randomized into this arm will undergo monitoring of oesophageal impedance
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Presence of pepsin in the saliva
The presence of pepsin in the saliva will be assessed.
Full Information
NCT ID
NCT03904758
First Posted
April 3, 2019
Last Updated
December 6, 2022
Sponsor
University Hospital Ostrava
1. Study Identification
Unique Protocol Identification Number
NCT03904758
Brief Title
Extraesophageal Reflux - Feasibility of Measurement of Pepsin in Saliva as a Diagnostic Option
Official Title
Extraesophageal Reflux - Feasibility of Measurement of Pepsin in Saliva as a Diagnostic Option
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Ostrava
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extraesophageal Reflux
Keywords
extraesophageal reflux, laryngopharyngeal reflux, pepsin, saliva, oropharyngeal pH monitoring, esophageal impedance
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The patients will be randomized into two study arms.
Masking
None (Open Label)
Masking Description
No masking will be used in the study.
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Monitoring of pH with Restech
Arm Type
Experimental
Arm Description
The patients with EER randomized into this arm will undergo pH monitoring using Restech system
Arm Title
Monitoring of oesophageal impedance
Arm Type
Experimental
Arm Description
The patients with EER randomized into this arm will undergo monitoring of oesophageal impedance
Intervention Type
Diagnostic Test
Intervention Name(s)
Pepsin in saliva test
Intervention Description
The presence of pepsin in the saliva will be tested in both groups of patients.
Primary Outcome Measure Information:
Title
Reflux symptom index (RSI)
Description
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
Title
Reflux finding score (RFS)
Description
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
Secondary Outcome Measure Information:
Title
Presence of pepsin in the saliva
Description
The presence of pepsin in the saliva will be assessed.
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Formánek, MD,PhD
Organizational Affiliation
University Hospital Ostrava
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ostrava
City
Ostrava
State/Province
Moravian-Silesian Region
ZIP/Postal Code
70852
Country
Czechia
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The investigators do not plan to share individual participant data with other researchers.
Learn more about this trial
Extraesophageal Reflux - Feasibility of Measurement of Pepsin in Saliva as a Diagnostic Option
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