Laryngopharyngeal Reflux DiseasePhase 4NCT07611162
Comparative Effectiveness of Alginate, Magaldrate, Sucralfate, Proton Pump Inhibitors, and Diet in Laryngopharyngeal Reflux Disease
A Phase 4 study testing Alginate, Magaldrate and Sucralfate in people with Laryngopharyngeal Reflux Disease, run by University of Mons at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laryngopharyngeal Reflux Disease
- What is being tested?
- Alginate, Magaldrate and Sucralfate
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteBelgium
- Study dates
- 1 May 2026to 1 May 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Positive 24-h HEMII-pH > 1 event
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site
University of Mons
Mons, 7000
Jérome R Lechien, MD, PhD, MS, FACS, +32 498 64 09 19, jerome.lechien@umons.ac.be
About this study
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.
Read more
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
- Conditions
- Laryngopharyngeal Reflux Disease
- Being tested
- Alginate, Magaldrate, Sucralfate, Proton Pump Inhibitor (PPI) Therapy, Diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlginateDrug
Use of Gaviscon anti-acid, anti-reflux
MagaldrateDrug
use of Riopan drug
SucralfateDrug
use of Kéal sucralfate
Proton Pump Inhibitor (PPI) TherapyDrug
Use of Omeprazole, Esomeprazole, Lansoprazole, Pantoprazole, Rabeprazole
DietBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Alginate | Active comparator | Not described Receives: Drug: Alginate |
| Magaldrate | Active comparator | Not described Receives: Drug: Magaldrate |
| Proton pump inhibitors | Active comparator | Not described Receives: Drug: Proton Pump Inhibitor (PPI) Therapy |
| Sucralfate | Active comparator | Not described Receives: Drug: Sucralfate |
| Anti-reflux diet | Active comparator | Not described Receives: Behavioral: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start1 May 2026 (estimated)
- Primary completion1 May 2030 (estimated)
- Study completion1 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngopharyngeal Reflux DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Mons
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jerome lechien, University of Mons
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07611162
- Sponsor's protocol ID
- CE/220217
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 28 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Alginate, Magaldrate, Sucralfate, Proton Pump Inhibitors, and Diet in Laryngopharyngeal Reflux Disease
- ClinicalTrials.gov ID
- NCT07611162
- Acronym / sponsor ID
- CE/220217
- Conditions
- Laryngopharyngeal Reflux Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University of MonsUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 May 2030 (estimated)
- Study completion
- 1 May 2030 (estimated)
- First posted
- 28 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Alginate | Active comparator | Drug: Alginate |
| Magaldrate | Active comparator | Drug: Magaldrate |
| Proton pump inhibitors | Active comparator | Drug: Proton Pump Inhibitor (PPI) Therapy |
| Sucralfate | Active comparator | Drug: Sucralfate |
| Anti-reflux diet | Active comparator | Behavioral: Diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Positive 24-h HEMII-pH > 1 event
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlginateUse of Gaviscon anti-acid, anti-reflux | Drug | Alginate |
| Magaldrateuse of Riopan drug | Drug | Magaldrate |
| Sucralfateuse of Kéal sucralfate | Drug | Sucralfate |
| Proton Pump Inhibitor (PPI) TherapyUse of Omeprazole, Esomeprazole, Lansoprazole, Pantoprazole, Rabeprazole | Drug | Proton pump inhibitors |
| DietPatients 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. | Behavioural | Anti-reflux diet |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alginate, Magaldrate and Sucralfate in people with Laryngopharyngeal Reflux Disease, run by University of Mons at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jérome R Lechien, MD, PhD, MS, FACS (+32 498 64 09 19, jerome.lechien@umons.ac.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.