Mechanism-guided treatment versus proton-pump inhibitor therapy for chronic throat symptoms
The MVP Trial: A Randomized Controlled Trial of Mechanism Guided vs PPI Strategy for Laryngopharyngeal Reflux
This trial will test whether a mechanism-guided approach combining personalized acid-suppression and voice therapy helps adults (18–89) with chronic throat symptoms more than usual proton pump inhibitor (PPI) treatment.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 1 site (San Deigo, California) |
| Trial ID | NCT06999577 on ClinicalTrials.gov |
What this trial studies
Adults referred for evaluation of laryngopharyngeal reflux (LPR) who undergo endoscopy and ambulatory reflux monitoring off acid suppression are randomized 1:1 to a mechanism-guided strategy or to usual-care PPI therapy in an 8-week blinded phase. The mechanism-guided arm personalizes use of acid suppression and provides laryngeal recalibration/voice therapy plus GERD lifestyle advice, while the usual-care arm receives standard PPI-based management (omeprazole 40 mg or matched placebo during the blinded phase). Primary comparison is the proportion of participants achieving a predefined symptom response after the intervention period. Participants are assessed with baseline clinical testing and follow-up visits at the study site in San Diego.
Who should consider this trial
Good fit: Adults aged 18–89 with at least 8 weeks of laryngeal symptoms who are undergoing standard evaluation for LPR including endoscopy and reflux monitoring off acid suppression are ideal candidates.
Not a fit: Patients with PPI intolerance, prior foregut surgery, achalasia, active tobacco use, pregnancy or breastfeeding, inability to undergo reflux monitoring, or clear esophageal mucosal disease are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could improve symptom control and reduce unnecessary prolonged PPI use by tailoring treatment to the underlying mechanisms of throat symptoms.
How similar studies have performed: Standard PPI therapy is commonly used for these symptoms but prior randomized data are mixed, and mechanism-guided personalized approaches are relatively novel with limited randomized evidence to date.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Deigo, California
- University of California San Diego — San Deigo, California, United States (Recruiting)
Study contacts
- Principal investigator: Rena Yadlapati, MD — UC San Diego Health
- Study coordinator: Lorijane Robles
- Email: esophagealresearch@health.ucsd.edu
- Phone: 858-246-5236
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.