Comparative Effectiveness of Alginate, Magaldrate, Sucralfate, Proton Pump Inhibitors, and Diet in Laryngopharyngeal Reflux Disease
1 other identifier
interventional
800
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2026
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 15, 2026
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedFirst Posted
Study publicly available on registry
May 28, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2030
May 28, 2026
April 1, 2026
4 years
April 15, 2026
May 20, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (5)
Alginate
ACTIVE COMPARATORMagaldrate
ACTIVE COMPARATORProton pump inhibitors
ACTIVE COMPARATORSucralfate
ACTIVE COMPARATORAnti-reflux diet
ACTIVE COMPARATORInterventions
Use of Omeprazole, Esomeprazole, Lansoprazole, Pantoprazole, Rabeprazole
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.
Eligibility Criteria
You may qualify if:
- Positive 24-h HEMII-pH \> 1 event
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Mons
Mons, 7000, Belgium
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chairman & Professor of General Surgery
Study Record Dates
First Submitted
April 15, 2026
First Posted
May 28, 2026
Study Start
May 1, 2026
Primary Completion (Estimated)
May 1, 2030
Study Completion (Estimated)
May 1, 2030
Last Updated
May 28, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share