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

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

Treatments tested in this trial

  • Alginate
  • Magaldrate
  • Sucralfate
  • Proton Pump Inhibitor (PPI) Therapy
  • Diet

Treatment groups

800 Participants
are divided into 5 treatment groups

Sponsors and collaborators