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

ConditionLaryngopharyngeal Reflux Disease

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Mons

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Positive 24-h HEMII-pH > 1 event

Disqualifiers

Smoker (>5 cigarettes/day) , alcohol dependence (>3 units/day),

upper respiratory tract infection within the last month,

pregnancy,

neurological or psychiatric illness,

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

800 Participants

are divided into 5 treatment groups

Group A: AlginateActive comparator 1 intervention

Group B: MagaldrateActive comparator 1 intervention

Group C: Proton pump inhibitorsActive comparator 1 intervention

Group D: SucralfateActive comparator 1 intervention

Group E: Anti-reflux dietActive comparator 1 intervention

Trial outcomes

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.

Time frame

From enrollment to the end of treatment at 3 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Mons

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: