The Mechanism Versus PPI Trial

Summary

The goal of this clinical trial is to learn if a mechanism guided strategy that utilizes a multidisciplinary approach to treat adults patients (age 18-89) with chronic throat symptoms who are undergoing clinical evaluation for laryngopharyngeal reflux (LPR) is more effective than the usual care strategy with proton pump inhibitor (PPI) therapy used in gastroenterology for these patients.

The main question it aims to answer is: Will a greater proportion of the mechanism guided strategy participants achieve symptom response in comparison to the usual care strategy participants?

If there is a comparison group: Researchers will compare the mechanism guided strategy to usual care strategy to see if treatment response differs between the groups.

Participants will be be asked to do the following:

* participate in an 8-week blinded study phase where they will be randomized to either 1) Mechanism Guided Strategy or 2) Usual Care Strategy
* take an oral capsule daily (omeprazole 40mg or placebo)
* come to 3 in-person visits at UC San Diego Health for an intervention visit with a study provider
* consider incorporating recommended lifestyle modifications
* complete weekly surveys

Conditions

• Laryngopharyngeal Reflux
• Cough
• Throat Clearing
• Dysphonia
• Reflux

Interventions

DRUG

Omeprazole 40 MG

8 week double dose therapy of proton pump inhibitor or placebo.

BEHAVIORAL

Laryngeal Recalibration Therapy

LRT utilizes therapies that SLPs standardly utilize (mechanical and cognitive guidance) in combination specifically designed to treat laryngeal symptoms. Each session with the SLP will guide subjects through these therapies. The existing script-based LRT protocol consists of the following: 1) mechanical guidance (laryngeal suppression, voice production, breath coordination), 2) cognitive guidance (identification of thinking patterns, recalibration of thoughts about laryngeal sensations).

BEHAVIORAL

GERD Lifestyle Recommendations

This is the typical lifestyle recommendations for GERD used clinically.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• University of California, San Diego

  lead OTHER

Principal Investigators

• Rena Yadlapati, MD · UC San Diego Health

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

89 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-04

Primary Completion

2029-05-01

Completion

2029-07-01

FDA Drug

Yes

Countries

• United States