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

University of Mons

Status and phase: Not yet enrolling; Phase 4

Conditions: Laryngopharyngeal Reflux Disease

Treatments: Behavioral: Diet; Drug: Alginate; Drug: Proton Pump Inhibitor (PPI) Therapy; Drug: Sucralfate; Drug: Magaldrate

Study type: Interventional

Funder types: Other

Identifiers

NCT07611162

CE/220217

Details and patient eligibility

About

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

Enrollment: 800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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800 participants in 5 patient groups

Alginate

Active Comparator group

Treatment:

Drug: Alginate

Magaldrate

Active Comparator group

Treatment:

Drug: Magaldrate

Proton pump inhibitors

Active Comparator group

Treatment:

Drug: Proton Pump Inhibitor (PPI) Therapy

Sucralfate

Active Comparator group

Treatment:

Drug: Sucralfate

Anti-reflux diet

Active Comparator group

Treatment:

Behavioral: Diet