NCT06999577 · University of California, San Diego
The Mechanism Versus PPI Trial
(MVP)
What this study is about
The goal of this clinical trial is to learn if a mechanism guided strategy that utilizes a multidisciplinary approach to treat adults patients (age 18-89) with chronic throat symptoms who are undergoing clinical evaluation for laryngopharyngeal reflux (LPR) is more effective than the usual care strategy with proton pump inhibitor (PPI) therapy used in gastroenterology for these patients.
View original scientific description
The goal of this clinical trial is to learn if a mechanism guided strategy that utilizes a multidisciplinary approach to treat adults patients (age 18-89) with chronic throat symptoms who are undergoing clinical evaluation for laryngopharyngeal reflux (LPR) is more effective than the usual care strategy with proton pump inhibitor (PPI) therapy used in gastroenterology for these patients. The main question it aims to answer is: Will a greater proportion of the mechanism guided strategy participants achieve symptom response in comparison to the usual care strategy participants? If there is a comparison group: Researchers will compare the mechanism guided strategy to usual care strategy to see if treatment response differs between the groups.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 18-89 years of age
- \>8 weeks of laryngeal symptoms (cough, throat clearing, dysphonia)
- Standard evaluation for LPR, undergoing EGD (with endoscopic evaluation of the hypopharynx) and reflux monitoring off acid suppression
- Off acid suppression therapy for at least 2 weeks prior to randomization.
Exclusion criteria
- PPI intolerance and/or known hypersensitivity to the formulation or substituted benzimidazoles
- History of foregut surgery
- Known diagnosis of achalasia
- Inability to fast for 4 hours (no food or drink)
- Active tobacco use
- Pregnant or breastfeeding
- Unable to consent in English or Spanish
- Unable to provide consent without a legal guardian or representative
- Endoscopic findings conclusive with esophageal mucosal abnormalities
- Unable to proceed with reflux monitoring
- Use of acid suppression during the reflux monitoring and/or before the study medication (omeprazole or placebo) is dispensed
- Prior LRT for reflux related symptoms
- History of major psychiatric comorbidity
- Unable to attend in person study visits at UCSD
Where
- San Deigo, California
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 1, 2025 · Source of record for eligibility and locations