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| Name | Class |
|---|---|
| Rosa Biotech | UNKNOWN |
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Comparing the fluorescence signatures from mouthwash samples of patients with laryngopharyngeal reflux (LPR) and healthy volunteers.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with symptoms of LPR and objective evidence of GORD |
| ||
| Patients with symptoms of LPR and no objective evidence of GORD |
| ||
| Healthy volunteers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 24-hour pH-impedance monitoring | Diagnostic Test | Ambulatory transnasal reflux device to detect reflux events in the oeosphagus and pharynx. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine the detection strength of differences in fingerprints between the three participant groups. | 10-months |
| Measure | Description | 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 |
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Healthy Volunteers
Inclusion Criteria:
Exclusion Criteria:
Patients with symptoms of LPR
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Functional Gut Clinic | Recruiting | Manchester | Greater Manchester | M3 4BG | United Kingdom |
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| ID | Term |
|---|---|
| D057045 | Laryngopharyngeal Reflux |
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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Mouthwash (salivary oral rinse)
| Symptom questionnaires | Other | Reflux Symptom Index (RSI) Gastroesophageal Reflux Disease Questionnaire (GERDQ) Short-form Esophageal Hypervigilance and Anxiety Scale (SF-EHAS) |
|
| ROME IV Diagnostic Questionnaire | Other | A symptom-based questionnaire used to diagnose disorders of gut-brain interaction (DGBI) |
|
| D004066 | Digestive System Diseases |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |