Clinical trial NCT05204303: LPR Fluorescence Pilot
Official title: Analysis of Mouthwash Samples From Laryngopharyngeal Reflux (LPR) Patients and Healthy Volunteers Using Barrel-array Diagnostics
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Laryngopharyngeal Reflux
Gastro Esophageal Reflux
Lead sponsor: The Functional Gut Clinic
Sponsor class: OTHER
Collaborators: name: Rosa Biotech
First posted: 2022-01-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with LPR symptoms referred for ambulatory pH-impedance monitoring will be separated into two groups following completion of the pH-impedance test: those with objective evidence of GORD and those without objective evidence of GORD.

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

Detailed 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

Eligibility 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)

Primary outcomes:
measure: Determine the detection strength of differences in fingerprints between the three participant groups.
timeFrame: 10-months
Secondary outcomes:
measure: Determine the differences in fingerprints between samples within one group to assess background noise.
timeFrame: 10-months
measure: Determine the feasibility of mouthwash on Pandra platform.
timeFrame: 10-months
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: The Functional Gut Clinic
state: Greater Manchester
Study officials:
References: