Gastro Esophageal Reflux, Laryngopharyngeal Reflux
Conditions
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
Interventions
DIAGNOSTIC_TEST24-hour pH-impedance monitoring
Ambulatory transnasal reflux device to detect reflux events in the oeosphagus and pharynx.
Reflux Symptom Index (RSI) Gastroesophageal Reflux Disease Questionnaire (GERDQ) Short-form Esophageal Hypervigilance and Anxiety Scale (SF-EHAS)
OTHERROME IV Diagnostic Questionnaire
A symptom-based questionnaire used to diagnose disorders of gut-brain interaction (DGBI)
Sponsors
Rosa Biotech
The Functional Gut Clinic
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the detection strength of differences in fingerprints between the three participant groups. | 10-months |
Secondary
| Measure | 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 |
Countries
United Kingdom
Outcome results
None listed