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Clinical Trials/NCT07611162
NCT07611162Not yet recruitingPhase 4

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

University of Mons1 site in 1 country800 target enrollmentStarted: May 1, 2026Last updated:
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Trial Snapshot

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Enrollment
800
Locations
1
Study OverviewStudy DesignEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Investigators

Sponsor
University of Mons
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jerome lechien

Chairman & Professor of General Surgery

University of Mons

Study Sites (1)

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