A Study Comparing a Personalized Mechanism Guided Treatment to Usual Proton Pump Inhibitor Care for Adults With Chronic Throat Symptoms Related to Laryngopharyngeal Reflux

What this Trial Is About

Researchers are evaluating if a mechanism guided strategy that uses a multidisciplinary approach is more effective than the usual care with proton pump inhibitor PPI therapy for adults aged 18 to 89 with chronic throat symptoms undergoing clinical evaluation for laryngopharyngeal reflux LPR. This trial aims to determine whether more participants receiving the mechanism guided strategy experience symptom improvement compared to those receiving usual care. Participants will be randomly assigned to one of two groups for an 8-week treatment period the mechanism guided strategy or the usual care strategy. The mechanism guided group receives omeprazole 40mg daily if tests confirm GERD and placebo otherwise, combined with Laryngeal Recalibration Therapy LRT involving mechanical and cognitive guidance by a speech language pathologist, plus lifestyle advice. The usual care group receives omeprazole 40mg daily regardless of test results along with standard lifestyle counseling. Both groups take oral capsules daily and attend three in-person intervention visits during weeks 1, 4, and 8. Participants will complete weekly online surveys about medication adherence and lifestyle changes and undergo assessments at each visit including acoustics, aerodynamics, symptom and quality of life questionnaires, saliva sample analysis, and physiological measures. Data on height, weight, medications, and adverse events will also be collected. After the final visit, participants learn their assigned treatment and are returned to usual clinical care. The study monitors symptom response over five years, with safety considerations including possible side effects of omeprazole.

The Mechanism Versus PPI Trial