Laryngopharyngeal Reflux Disease
Conditions
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
Interventions
DRUGAlginate
Use of Gaviscon anti-acid, anti-reflux
DRUGMagaldrate
use of Riopan drug
DRUGSucralfate
use of Kéal sucralfate
Use of Omeprazole, Esomeprazole, Lansoprazole, Pantoprazole, Rabeprazole
BEHAVIORALDiet
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.
Sponsors
University of Mons
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | 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 |
Countries
Belgium
Contacts
CONTACTJérome R Lechien, MD, PhD, MS, FACS
Outcome results
None listed