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 range

18 Years

Sex

ALL

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Determine the detection strength of differences in fingerprints between the three participant groups.

Timeframe: 10-months

Trial details

NCT IDNCT05204303

SponsorThe Functional Gut Clinic

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-06

View on ClinicalTrials.gov More Laryngopharyngeal Reflux trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.