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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alginate | Active Comparator |
| |
| Magaldrate | Active Comparator |
| |
| Proton pump inhibitors | Active Comparator |
| |
| Sucralfate | Active Comparator |
| |
| Anti-reflux diet | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alginate | Drug | Use of Gaviscon anti-acid, anti-reflux |
| |
| Magaldrate |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jérome R Lechien, MD, PhD, MS, FACS | Contact | +32 498 64 09 19 | jerome.lechien@umons.ac.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Mons | Mons | 7000 | Belgium |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 14, 2026 |
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| 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. |
|
| May 20, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000464 | Alginates |
| C016545 | magaldrate |
| D013392 | Sucralfate |
| D054328 | Proton Pump Inhibitors |
| D013812 | Therapeutics |
| D004032 | Diet |
| ID | Term |
|---|---|
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D013865 | Thioglycosides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D013395 | Sucrose |
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D000073893 | Sugars |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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