The Mechanism Versus PPI Trial
Launched by UNIVERSITY OF CALIFORNIA, SAN DIEGO · May 22, 2025
Trial Information
Current as of July 25, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
The MVP Trial is a clinical study that aims to find out if a new treatment approach called the "mechanism guided strategy" is more effective than the usual care for adults experiencing chronic throat symptoms due to a condition called laryngopharyngeal reflux (LPR). This condition can cause symptoms like chronic cough, throat clearing, and voice changes. The trial will compare how well these two strategies work by looking at which group of patients reports better symptom relief after treatment.
To participate, you need to be between 18 and 89 years old and have had throat symptoms for more than 8 weeks. Participants will be randomly assigned to either the new treatment approach or the usual care, which involves taking a daily capsule and attending three in-person visits at UC San Diego Health. During the study, you’ll also be asked to fill out weekly surveys and may consider some lifestyle changes to help improve your symptoms. The trial is not recruiting yet, but it’s a great opportunity for those who want to explore new options for their throat issues.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. 18-89 years of age
- • 2. \>8 weeks of laryngeal symptoms (cough, throat clearing, dysphonia)
- • 3. Standard evaluation for LPR, undergoing EGD (with endoscopic evaluation of the hypopharynx) and reflux monitoring off acid suppression
- • 4. Off acid suppression therapy for at least 2 weeks prior to randomization.
- Exclusion Criteria:
- • 1. PPI intolerance and/or known hypersensitivity to the formulation or substituted benzimidazoles
- • 2. History of foregut surgery
- • 3. Known diagnosis of achalasia
- • 4. Inability to fast for 4 hours (no food or drink)
- • 5. Active tobacco use
- • 6. Pregnant or breastfeeding
- • 7. Unable to consent in English or Spanish
- • 8. Unable to provide consent without a legal guardian or representative
- • 9. Imprisoned
- • 10. Endoscopic findings conclusive with esophageal mucosal abnormalities
- • 11. Unable to proceed with reflux monitoring
- • 12. Use of acid suppression during the reflux monitoring and/or before the study medication (omeprazole or placebo) is dispensed
- • 13. Prior LRT for reflux related symptoms
- • 14. History of major psychiatric comorbidity
- • 15. Unable to attend in person study visits at UCSD
About University Of California, San Diego
The University of California, San Diego (UCSD) is a leading academic institution renowned for its commitment to advancing healthcare through innovative research and clinical trials. With a robust focus on translational medicine, UCSD leverages its interdisciplinary approach to explore groundbreaking therapies and interventions across a wide range of medical fields. The university's state-of-the-art facilities and collaboration with top-tier faculty and researchers ensure a comprehensive and ethical framework for conducting clinical trials, ultimately aiming to enhance patient outcomes and contribute to the global body of medical knowledge.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
San Deigo, California, United States
Patients applied
Trial Officials
Rena Yadlapati, MD
Principal Investigator
UC San Diego Health
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported