The Mechanism Versus PPI Trial
Recruiting now · Phase 4 · Has a placebo group
Conditions studied: Laryngopharyngeal Reflux, Cough, Throat Clearing, Dysphonia, Reflux
In brief
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
Key facts
- Study ID
- NCT06999577
- Run by
- University of California, San Diego
- People needed
- 160
- Starts
- 2025-06-04
- Expected to finish
- 2029-07-01
- Last updated by the study team
- 2025-08-01
Who can join
Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 18-89 years of age
- >8 weeks of laryngeal symptoms (cough, throat clearing, dysphonia)
- Standard evaluation for LPR, undergoing EGD (with endoscopic evaluation of the hypopharynx) and reflux monitoring off acid suppression
- Off acid suppression therapy for at least 2 weeks prior to randomization.
You may not qualify if…
- PPI intolerance and/or known hypersensitivity to the formulation or substituted benzimidazoles
- History of foregut surgery
- Known diagnosis of achalasia
- Inability to fast for 4 hours (no food or drink)
- Active tobacco use
- Pregnant or breastfeeding
- Unable to consent in English or Spanish
- Unable to provide consent without a legal guardian or representative
- Imprisoned
- Endoscopic findings conclusive with esophageal mucosal abnormalities
- Unable to proceed with reflux monitoring
- Use of acid suppression during the reflux monitoring and/or before the study medication (omeprazole or placebo) is dispensed
- Prior LRT for reflux related symptoms
- History of major psychiatric comorbidity
- Unable to attend in person study visits at UCSD
Where it is running
- University of California San Diego — San Deigo, California, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.