# The MVP Trial: A Randomized Controlled Trial of Mechanism Guided vs PPI Strategy for Laryngopharyngeal Reflux

> **NIH NIH R01** · UNIVERSITY OF CALIFORNIA, SAN DIEGO · 2024 · $674,854

## Abstract

PROJECT ABSTRACT
Among the 20% of US adults experiencing laryngeal symptoms, 80% are diagnosed with laryngopharyngeal
reflux (LPR) based on symptoms alone and empirically treated with proton pump inhibitors (PPIs). However,
laryngeal symptoms respond poorly to PPIs, and patients often seek additional evaluation (on average 10
consultations & 6 diagnostic tests). Despite an arduous journey, patients rarely achieve clarity or relief. This
usual care approach for laryngeal symptoms significantly impairs quality of life, leads to PPI overuse, and
accounts for $50 billion in annual health care costs. The therapeutic dilemma is that varied mechanisms
beyond gastric acid contribute to laryngeal symptoms and, thus, acid suppression with PPI is insufficient as a
sole therapy. Through clinical trials and outcomes research, our team has identified novel mechanism targeted
laryngeal recalibration therapy to address hyper-responsive laryngeal mechanical and cognitive behaviors.
Another critical challenge is in the diagnosis of LPR. Our team has developed and validated an array of novel
metrics with tremendous diagnostic potential including acid exposure time, a risk prediction score and salivary
biomarkers (pepsin, bile acids). These cutting-edge discoveries in light of diagnostic and therapeutic gaps for
LPR indicate that a trial of mechanism guided versus usual care PPI is an urgent, unmet need. We are
uniquely positioned to address these critical gaps as we have assembled a multidisciplinary team with the
requisite expertise in clinical trials, esophageal physiology, laryngology and laryngeal recalibration therapy to
ensure successful design and high-quality execution of the MVP (Mechanism guided vs PPI) trial for LPR. This
randomized controlled trial (n=160) will compare a mechanism guided strategy which will provide laryngeal
recalibration therapy to all subjects as well as PPI to those with elevated esophageal acid versus the usual
care empiric PPI strategy in order to address two overarching aims. Specific Aim #1 will determine efficacy of a
mechanism guided strategy in patients undergoing evaluation for LPR; and, Specific Aim #2 will examine
performance characteristics of esophageal acid exposure, risk prediction score, and salivary biomarkers in
order to identify reliable diagnostic methods for the evaluation of LPR. The

## Key facts

- **NIH application ID:** 11045562
- **Project number:** 1R01DK139089-01A1
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN DIEGO
- **Principal Investigator:** Rena Hiren Yadlapati
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $674,854
- **Award type:** 1
- **Project period:** 2024-09-24 → 2029-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11045562

## Citation

> US National Institutes of Health, RePORTER application 11045562, The MVP Trial: A Randomized Controlled Trial of Mechanism Guided vs PPI Strategy for Laryngopharyngeal Reflux (1R01DK139089-01A1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/11045562. Licensed CC0.

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