LPR Fluorescence Pilot (NCT05204303) | Clinical Trial Compass
UnknownNot Applicable
LPR Fluorescence Pilot
United Kingdom100 participantsStarted 2022-07-01
Plain-language summary
Comparing the fluorescence signatures from mouthwash samples of patients with laryngopharyngeal reflux (LPR) and healthy volunteers.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
What they're measuring
1
Determine the detection strength of differences in fingerprints between the three participant groups.