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Search / Trial NCT06999577

The Mechanism Versus PPI Trial

Launched by UNIVERSITY OF CALIFORNIA, SAN DIEGO · May 22, 2025

Trial Information

Current as of July 22, 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.

Locations

San Deigo, California, United States

Patients applied

0 patients applied

Trial Officials

Rena Yadlapati, MD

Principal Investigator

UC San Diego Health

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported