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

NCT07611162 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2026-05-28

No results posted yet for this study

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

Conditions

  • Laryngopharyngeal Reflux Disease

Interventions

DRUG

Alginate

Use of Gaviscon anti-acid, anti-reflux

DRUG

Magaldrate

use of Riopan drug

DRUG

Sucralfate

use of Kéal sucralfate

DRUG

Proton Pump Inhibitor (PPI) Therapy

Use of Omeprazole, Esomeprazole, Lansoprazole, Pantoprazole, Rabeprazole

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.

Sponsors & Collaborators

  • University of Mons

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2030-05-01
Completion
2030-05-01

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07611162 on ClinicalTrials.gov