# Mechanism Guided Therapy for Laryngopharyngeal Reflux

> **NIH NIH K23** · UNIVERSITY OF CALIFORNIA, SAN DIEGO · 2023 · $192,365

## Abstract

PROJECT SUMMARY/ABSTRACT
Generalized approaches for laryngopharyngeal reflux (LPR), a prevalent and heterogeneous syndrome in
which laryngeal symptoms are attributed to gastroesophageal reflux, have led to poor health outcomes,
inappropriate resource utilization, and tremendous healthcare costs. As a physician scientist with advanced
training in esophageal physiology and health outcomes research, my long-term career goal is to discover
phenotype guided care paradigms for esophageal conditions, such as LPR, focused on distinct disease
mechanism. My preliminary findings from single-arm clinical trials, observational studies, and initial
translational research in LPR have generated the central hypothesis that novel diagnostic biomarkers can
identify clinical-physiologic phenotypes of LPR and guide a mechanism focused treatment strategy. Thus, the
research goals of this proposal are to (1) measure the efficacy of the novel therapeutic upper esophageal
sphincter assist device in a rigorous biomarker targeted randomized sham-controlled trial of 78 subjects with
salivary pepsin positive LPR, (2) identify phenotypes of LPR using latent class analysis of comprehensive
physiologic and clinical data, and (3) compare oral microbiome between subjects with and without pepsin
positive LPR. The research aims are aligned with my training goals to (1) develop expertise in advanced
clinical trial methods, (2) acquire skills in phenotype design and latent class analysis, and (3) obtain experience
with translational microbiome research. My outstanding and diverse mentorship team is overseen by primary
mentor Dr. Samir Gupta, an expert clinical trialist that has contributed seminal discoveries in colorectal cancer
screening. Co-mentors include Dr. John Pandolfino, a leading international authority and clinical researcher in
esophageal physiology, and Dr. Bernd Schnabl, a physician scientist that has pioneered work in host effects on
the intestinal microbiome. The exceptionally supportive and conducive institutional environment at University
of California San Diego (UCSD) is a key strength of this application. UCSD’s NIH supported Clinical
Translational Research Institute will provide cutting-edge clinical trial infrastructure. UCSD’s Center for
Esophageal Diseases and Center for Voice & Swallowing Disorders will ensure successful subject recruitment
and access to state-of-the-art diagnostic techniques. UCSD’s P30 supported Digestive Diseases Research
Center directed by Dr. Bernd Schnabl, will provide leading resources in microbiomics and bioinformatics.
Immediate anticipated impacts of this proposal are to inform the clinical management of LPR and shed light
on a novel mechanistic pathway of inflammation in LPR, as well as enhance my career by providing unique
skills in clinical trial methods and microbiome research. Ultimately, this career development proposal will
launch my career as an impactful leader in multi-disciplinary clinical-translational research in the fi...

## Key facts

- **NIH application ID:** 10596143
- **Project number:** 5K23DK125266-03
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN DIEGO
- **Principal Investigator:** Rena Hiren Yadlapati
- **Activity code:** K23 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $192,365
- **Award type:** 5
- **Project period:** 2021-05-07 → 2026-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10596143

## Citation

> US National Institutes of Health, RePORTER application 10596143, Mechanism Guided Therapy for Laryngopharyngeal Reflux (5K23DK125266-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10596143. Licensed CC0.

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