Actively Recruiting
The Mechanism Versus PPI Trial
Led by University of California, San Diego · Updated on 2025-08-01
160
Participants Needed
1
Research Sites
212 weeks
Total Duration
On this page
Sponsors
U
University of California, San Diego
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
The Mechanism Versus PPI Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 89 years
- Have had laryngeal symptoms (cough, throat clearing, dysphonia) for more than 8 weeks
- Undergoing standard evaluation for laryngopharyngeal reflux including upper endoscopy and reflux monitoring off acid suppression
- Off acid suppression therapy for at least 2 weeks before randomization
You will not qualify if you...
- Known intolerance or allergy to proton pump inhibitors or related drugs
- History of surgery on the upper digestive tract
- Diagnosed with achalasia
- Unable to fast for at least 4 hours
- Current tobacco use
- Pregnant or breastfeeding
- Unable to consent in English or Spanish
- Unable to provide consent without a legal guardian or representative
- Currently imprisoned
- Endoscopic findings showing esophageal mucosal abnormalities
- Unable to complete reflux monitoring
- Use of acid suppression medication during reflux monitoring or before study medication is given
- Previous laryngeal recalibration therapy for reflux symptoms
- History of major psychiatric disorders
- Unable to attend in-person study visits at UC San Diego Health
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of California San Diego
San Deigo, California, United States, 92093
Actively Recruiting
Research Team
L
Lorijane Robles
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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