The Mechanism Versus PPI Trial

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

NCT Number	NCT06999577
Lead Sponsor	University of California, San Diego Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions	Laryngopharyngeal Reflux, Cough, Throat Clearing, Dysphonia, Reflux
Enrollment	160 participants
Start Date	2025-06-04
Primary Completion	2029-05-01 (estimated)
Study Completion	2029-07-01 (estimated)
Updated on ClinicalTrials.gov	2025-08-01