The Mechanism Versus PPI Trial
The MVP Trial: A Randomized Controlled Trial of Mechanism Guided vs PPI Strategy for Laryngopharyngeal Reflux
University of California, San Diego
160 participants
Jun 4, 2025
INTERVENTIONAL
Conditions
Summary
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. Participants will be be asked to do the following: * participate in an 8-week blinded study phase where they will be randomized to either 1) Mechanism Guided Strategy or 2) Usual Care Strategy * take an oral capsule daily (omeprazole 40mg or placebo) * come to 3 in-person visits at UC San Diego Health for an intervention visit with a study provider * consider incorporating recommended lifestyle modifications * complete weekly surveys
Eligibility
Inclusion Criteria4
- 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 Criteria15
- 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
- Imprisoned
- 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
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Interventions
8 week double dose therapy of proton pump inhibitor or placebo.
LRT utilizes therapies that SLPs standardly utilize (mechanical and cognitive guidance) in combination specifically designed to treat laryngeal symptoms. Each session with the SLP will guide subjects through these therapies. The existing script-based LRT protocol consists of the following: 1) mechanical guidance (laryngeal suppression, voice production, breath coordination), 2) cognitive guidance (identification of thinking patterns, recalibration of thoughts about laryngeal sensations).
This is the typical lifestyle recommendations for GERD used clinically.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06999577