LPR Fluorescence Pilot

• Conditions: Laryngopharyngeal Reflux; Gastro Esophageal Reflux
• Interventions: Diagnostic Test: 24-hour pH-impedance monitoring; Other: Symptom questionnaires; Other: ROME IV Diagnostic Questionnaire

• Registration Number: NCT05204303
• Lead Sponsor: The Functional Gut Clinic

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

Study Timeline

• Study First Submitted: 2022-01-10
• Study First Submitted QC: 2022-01-10
• Study First Posted: 2022-01-24
• Study Start: 2022-07-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-30
• Last Update Posted: 2022-09-02
• Primary Completion: 2023-06
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with symptoms of LPR and no objective evidence of GORD	Symptom questionnaires	-
Patients with symptoms of LPR and objective evidence of GORD	Symptom questionnaires	-
Patients with symptoms of LPR and no objective evidence of GORD	24-hour pH-impedance monitoring	-
Patients with symptoms of LPR and no objective evidence of GORD	ROME IV Diagnostic Questionnaire	-
Patients with symptoms of LPR and objective evidence of GORD	24-hour pH-impedance monitoring	-
Patients with symptoms of LPR and objective evidence of GORD	ROME IV Diagnostic Questionnaire	-
Healthy volunteers	Symptom questionnaires	-
Healthy volunteers	ROME IV Diagnostic Questionnaire	-

Primary Outcome Measures

Name	Time	Method
Determine the detection strength of differences in fingerprints between the three participant groups.	10-months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The Functional Gut Clinic; 🇬🇧 Manchester, Greater Manchester, United Kingdom