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 pum
| Condition(s) | Laryngopharyngeal Reflux, Cough, Throat Clearing, Dysphonia, Reflux |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| 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: |
| Who can participate | Inclusion Criteria: 1. 18-89 years of age 2. \>8 weeks of laryngeal symptoms (cough, throat clearing, dysphonia) 3. Standard evaluation for LPR, undergoing EGD (with endoscopic evaluation of the hypopharynx) and reflux monitoring off acid suppression 4. Off acid suppression therapy for at least 2 weeks prior to randomization. Exclusion Criteria: 1. PPI intolerance and/or known hypersensitivity to the formulation or substituted benzimidazoles 2. History of foregut surgery 3. Known diagnosis of achalasia 4. Inability to fast for 4 hours (no food or drink) 5. Active tobacco use 6. Pregnant or breastfeeding 7. Unable to consent in English or Spanish 8. Unable to provide consent without a legal guardian or representative 9. Imprisoned 10. Endoscopic findings conclusive with esophageal mucosal a |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Lead sponsor | University of California, San Diego |
| Locations | San Deigo, California, United States |
| Start date | 2025-06-04 |
| NCT ID | NCT06999577 |
| Official listing | https://clinicaltrials.gov/study/NCT06999577 |