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

NCT07611162 — Phase 4, Not yet recruiting, 800 participants, University of Mons

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Registry	NCT07611162
Status	Not yet recruiting
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	800 (Estimated)
Sponsor	University of Mons (Other)
Conditions	Laryngopharyngeal Reflux Disease
Interventions	Alginate, Magaldrate, Sucralfate, Proton Pump Inhibitor (PPI) Therapy, Diet (Drug, behavioral)
Dates	start 2026-05-01 (estimated), primary completion 2030-05-01 (estimated), completion 2030-05-01 (estimated), first posted 2026-05-28, last updated 2026-05-28
Locations	1 site in Belgium

-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

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+Arms and interventions

Arm	Type	Interventions
Alginate	Active comparator	Drug: Alginate
Magaldrate	Active comparator	Drug: Magaldrate
Proton pump inhibitors	Active comparator	Drug: Proton Pump Inhibitor (PPI) Therapy
Sucralfate	Active comparator	Drug: Sucralfate
Anti-reflux diet	Active comparator	Behavioral: Diet

Alginate (Drug): Use of Gaviscon anti-acid, anti-reflux
Magaldrate (Drug): use of Riopan drug
Sucralfate (Drug): use of Kéal sucralfate
Proton Pump Inhibitor (PPI) Therapy (Drug): Use of Omeprazole, Esomeprazole, Lansoprazole, Pantoprazole, Rabeprazole
Diet (Behavioral): Patients are recommended to adhere to a 3-month low-fat, low quick-release sugar, high-protein, alkaline, and plant-based diet. The consumption of fish and meat was authorized but reduced to low-fat fish and meat. The anti-reflux diet considered the exclusion/reduction of additional triggers such as caffeine or theine, spices, tomatoes, fatty, cheese alcohol, and sparkling beverages.

+Outcome measures

Primary outcomes

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. [From enrollment to the end of treatment at 3 months]

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
University of Mons	Mons	Belgium

+Study documents

Study Protocol and Statistical Analysis Plan (PDF, 2026-04-14)