Not Yet RecruitingPhase 4

Comparative Effectiveness of Alginate, Magaldrate, Sucralfate, Proton Pump Inhibitors, and Diet in Laryngopharyngeal Reflux Disease

Belgium800 participantsStarted 2026-05-01

Plain-language summary

The goal of this randomized controlled trial is to compare the effectiveness of different treatments for laryngopharyngeal reflux disease (LPRD) in adult patients with confirmed symptoms and signs of the condition. The main question it aims to answer is: Which treatment (Proton Pump Inhibitors (PPIs), alginate, magaldrate, sucralfate, or diet) leads to the greatest improvement in LPRD symptoms and clinical signs over 3 months? Researchers will compare proton pump inhibitors to alternative medical treatments and dietary management to see which approach is most effective and better tolerated. Participants will: * undergo a clinical ENT examination with scoring of reflux signs (RSA) * complete symptom questionnaires (RSS) assessing severity, frequency, and impact of symptoms * receive one of the study treatments (medication or dietary intervention) * be evaluated at baseline and again after 3 months of treatment

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.

Inclusion Criteria: * Positive 24-h HEMII-pH \> 1 event Exclusion Criteria: * Smoker (\>5 cigarettes/day) , alcohol dependence (\>3 units/day), * upper respiratory tract infection within the last month, * pregnancy, * neurological or psychiatric illness, * previous history of neck surgery or trauma, * malignancy, * history of head and neck radiotherapy * active seasonal allergies or asthma.

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

Comparison of the effectiveness of each intervention based on changes in Reflux Symptom Score (RSS) and Reflux Sign Assessment (RSA) from pre- to post-treatment follow-up.

Timeframe: From enrollment to the end of treatment at 3 months

Trial details

NCT IDNCT07611162

SponsorUniversity of Mons

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-05-01

Contact for this trial

Jérome R Lechien, MD, PhD, MS, FACS

+32 498 64 09 19 jerome.lechien@umons.ac.be

View on ClinicalTrials.gov More Laryngopharyngeal Reflux Disease trials