NCT05204303

LPR Fluorescence Pilot

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: The Functional Gut Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• Laryngopharyngeal Reflux
• Gastro Esophageal Reflux

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	24-hour pH-impedance monitoring	Ambulatory transnasal reflux device to detect reflux events in the oeosphagus and pharynx.
OTHER	Symptom questionnaires	Reflux Symptom Index (RSI) Gastroesophageal Reflux Disease Questionnaire (GERDQ) Short-form Esophageal Hypervigilance and Anxiety Scale (SF-EHAS)
OTHER	ROME IV Diagnostic Questionnaire	A symptom-based questionnaire used to diagnose disorders of gut-brain interaction (DGBI)

Timeline

• Start date: 2022-07-01
• Primary completion: 2023-06-01
• Completion: 2023-07-01
• First posted: 2022-01-24
• Last updated: 2022-09-02

Locations

1 site across 1 country: United Kingdom