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NCT Number: NCT07611162

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

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

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Key information

Conditions

Laryngopharyngeal Reflux Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

    Time frame: From enrollment to the end of treatment at 3 months

Study contacts

Contact information is provided by the study sponsor or research team.

Jérome R Lechien, MD, PhD, MS, FACS

CONTACT

[email protected]

+32 498 64 09 19

Sponsors and collaborators

Lead sponsor

University of Mons

Other

Registry information

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
May 28, 2026
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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