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The Mechanism Versus PPI Trial

RecruitingPhase 4Ages 18 Years - 89 YearsAllUniversity of California, San Diego
NCT06999577 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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) Mecha

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📋 Eligibility rules (as published)
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 abnormalities 11. Unable to proceed with reflux monitoring 12. Use of acid suppression during the reflux monitoring and/or before the study medication (omeprazole or placebo) is dispensed 13. Prior LRT for reflux related symptoms 14. History of major psychiatric comorbidity 15. Unable to attend in person study visits at UCSD
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What it tests

  • Omeprazole 40 MG
  • Laryngeal Recalibration Therapy
  • GERD Lifestyle Recommendations
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Where

1 site
University of California San Diego
San Deigo, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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