LPR Fluorescence Pilot

The Functional Gut Clinic

Status

Enrolling

Conditions

Gastro Esophageal Reflux

Laryngopharyngeal Reflux

Treatments

Other: Symptom questionnaires

Diagnostic Test: 24-hour pH-impedance monitoring

Other: ROME IV Diagnostic Questionnaire

Study type

Observational

Funder types

Other

Identifiers

NCT05204303

FGC-22-001

Details and patient eligibility

About

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

Full description

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

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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)