LPR Fluorescence Pilot

Study Overview
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Brief Summary
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Comparing the fluorescence signatures from mouthwash samples of patients with laryngopharyngeal reflux (LPR) and healthy volunteers.

Detailed Description
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The investigators aim to test if the biosensing platform Pandra, developed by Rosa Biotech, may be suitable to distinguish patients with LPR symptoms, both with and without objective evidence of gastroesophageal reflux disease (GORD), vs healthy volunteers due to their expected inflammation and cell changes in the laryngo-pharyngeal region. The investigators intend to analyse 20 samples of mouthwash solutions from each of the following groups: A. Patients with symptoms of LPR and objective evidence of GORD B. Patients with symptoms of LPR and no objective evidence of GORD C. Healthy volunteer group

Official Title
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Analysis of Mouthwash Samples From Laryngopharyngeal Reflux (LPR) Patients and Healthy Volunteers Using Barrel-array Diagnostics

Conditions
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Laryngopharyngeal Reflux, Gastro Esophageal Reflux

Intervention / Treatment
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* Diagnostic Test: 24-hour pH-impedance monitoring
* Other: Symptom questionnaires
* Other: ROME IV Diagnostic Questionnaire


Participation Criteria
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Eligibility Criteria
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Healthy Volunteers Inclusion Criteria: Participant is Aged 18 or above Participant has capacity to understand written English Participant is not on regular prescription medicines Participant has an RSI score of 0 Participant has a body mass index (BMI) of 18.5 - 34.9 kg/m2 (bounds included) Exclusion Criteria: Participant has experienced any symptoms of LPR or GORD symptoms in the past year Participant has taken any medication for GORD/LPR in the past year (e.g. proton pump inhibitors, h2 antagonists, over the counter antacids) Participant has active oral disease Participant has a significant medical diagnosis Patients with symptoms of LPR Inclusion Criteria: Participant is Aged 18 or above Participant has capacity to understand written English Participant has an RSI score of >13 Participant has a body mass index (BMI) of 18.5 - 34.9 kg/m2 (bounds included Participant has been referred for 24hr ambulatory pH-impedance monitoring Exclusion Criteria: Participant has active oral disease Participant has other ongoing health problems that could account for their LPR symptoms. Participant has NOT undergone nasoendoscopy within last 6 months OR does not have one scheduled within next 6 weeks Previous antireflux surgery (e.g. fundoplication or magnetic sphincter augmentation) Previous bariatric surgery (e.g. gastric bypass or sleeve gastrectomy)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with symptoms of LPR and objective evidence of GORD<br> | Diagnostic Test: 24-hour pH-impedance monitoring<br>* Ambulatory transnasal reflux device to detect reflux events in the oeosphagus and pharynx.<br>Other: Symptom questionnaires<br>* Reflux Symptom Index (RSI) Gastroesophageal Reflux Disease Questionnaire (GERDQ) Short-form Esophageal Hypervigilance and Anxiety Scale (SF-EHAS)<br>Other: ROME IV Diagnostic Questionnaire<br>* A symptom-based questionnaire used to diagnose disorders of gut-brain interaction (DGBI)<br>|
| Patients with symptoms of LPR and no objective evidence of GORD<br> | Diagnostic Test: 24-hour pH-impedance monitoring<br>* Ambulatory transnasal reflux device to detect reflux events in the oeosphagus and pharynx.<br>Other: Symptom questionnaires<br>* Reflux Symptom Index (RSI) Gastroesophageal Reflux Disease Questionnaire (GERDQ) Short-form Esophageal Hypervigilance and Anxiety Scale (SF-EHAS)<br>Other: ROME IV Diagnostic Questionnaire<br>* A symptom-based questionnaire used to diagnose disorders of gut-brain interaction (DGBI)<br>|
| Healthy volunteers<br> | Other: Symptom questionnaires<br>* Reflux Symptom Index (RSI) Gastroesophageal Reflux Disease Questionnaire (GERDQ) Short-form Esophageal Hypervigilance and Anxiety Scale (SF-EHAS)<br>Other: ROME IV Diagnostic Questionnaire<br>* A symptom-based questionnaire used to diagnose disorders of gut-brain interaction (DGBI)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the detection strength of differences in fingerprints between the three participant groups. |  | 10-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the differences in fingerprints between samples within one group to assess background noise. |  | 10-months | 
| Determine the feasibility of mouthwash on Pandra platform. |  | 10-months |