Laryngopharyngeal Reflux clinical trials at UCSD

This 12 week biomarker targeted double blind randomized controlled trial (RCT) will enroll subjects with salivary pepsin positive laryngopharyngeal reflux (LPR) to assess efficacy of the external upper esophageal sphincter (UES) compression device, also known as the Reflux Band. Subjects will be randomized to one of two arms: control or experimental. Following the 8 week intervention period subjects in both arms will continue in a 4 week unblinded period. The primary hypothesis is that a significantly higher proportion of subjects in the experimental arm will meet the primary endpoint for symptom response, compared to subjects in the control arm.

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