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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Laryngopharyngeal Reflux Disease
• Intervention / Treatment: Drug: Alginate; Drug: Magaldrate; Drug: Proton Pump Inhibitor (PPI) Therapy; Drug: Sucralfate; Behavioral: Diet

• Study Type: Interventional
• Enrollment (Estimated): 800
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jérome R Lechien, MD, PhD, MS, FACS; Phone Number: +32 498 64 09 19; Email: jerome.lechien@umons.ac.be

Study Locations

• Belgium
  • Mons, Belgium, 7000
    • University of Mons
    • Contact: Jérome R Lechien, MD, PhD, MS, FACS; Phone Number: +32 498 64 09 19; Email: jerome.lechien@umons.ac.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Alginate	Drug: Alginate; Use of Gaviscon anti-acid, anti-reflux
Active Comparator: Magaldrate	Drug: Magaldrate; use of Riopan drug
Active Comparator: Proton pump inhibitors	Drug: Proton Pump Inhibitor (PPI) Therapy; Use of Omeprazole, Esomeprazole, Lansoprazole, Pantoprazole, Rabeprazole
Active Comparator: Sucralfate	Drug: Sucralfate; use of Kéal sucralfate
Active Comparator: Anti-reflux diet	Behavioral: Diet; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Mons

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2030

Study Registration Dates

• First Submitted: April 15, 2026
• First Submitted That Met QC Criteria: May 20, 2026
• First Posted (Actual): May 28, 2026

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Sulfur Compounds; Organic Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Diet, Food, and Nutrition; Physiological Phenomena; Carbohydrates; Nutritional Physiological Phenomena; Polysaccharides; Disaccharides; Oligosaccharides; Sugars; Thioglycosides; Sucrose; Proton Pump Inhibitors; Sucralfate; Diet; Therapeutics; Alginates; magaldrate
• Other Study ID Numbers: CE/220217

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No