Comparative Effectiveness of Alginate, Magaldrate, Sucralfate, Proton Pump Inhibitors, and Diet in Laryngopharyngeal Reflux Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Alginate, Magaldrate, Sucralfate, Proton Pump Inhibitor (PPI) Therapy.
- Who it may be relevant to
- Registry conditions: Laryngopharyngeal Reflux Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
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.
Primary outcome measures
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Belgium · 1 center
- University of Mons — Mons
Identifiers
NCT: NCT07611162 · CE/220217