Actively Recruiting
The MVP Trial: Comparing Mechanism Guided Strategy Versus Proton Pump Inhibitor Therapy for Laryngopharyngeal Reflux
Led by University of California, San Diego · Updated on 2025-08-01
160
Participants Needed
1
Research Sites
8 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
Researchers are evaluating if a mechanism guided strategy that uses a multidisciplinary approach is more effective than the usual care with proton pump inhibitor (PPI) therapy for adults aged 18 to 89 with chronic throat symptoms undergoing clinical evaluation for laryngopharyngeal reflux (LPR). This trial aims to determine whether more participants receiving the mechanism guided strategy experience symptom improvement compared to those receiving usual care. Participants will be randomly assigned to one of two groups for an 8-week treatment period: the mechanism guided strategy or the usual care strategy. The mechanism guided group receives omeprazole 40mg daily if tests confirm GERD and placebo otherwise, combined with Laryngeal Recalibration Therapy (LRT) involving mechanical and cognitive guidance by a speech language pathologist, plus lifestyle advice. The usual care group receives omeprazole 40mg daily regardless of test results along with standard lifestyle counseling. Both groups take oral capsules daily and attend three in-person intervention visits during weeks 1, 4, and 8. Participants will complete weekly online surveys about medication adherence and lifestyle changes and undergo assessments at each visit including acoustics, aerodynamics, symptom and quality of life questionnaires, saliva sample analysis, and physiological measures. Data on height, weight, medications, and adverse events will also be collected. After the final visit, participants learn their assigned treatment and are returned to usual clinical care. The study monitors symptom response over five years, with safety considerations including possible side effects of omeprazole.
CONDITIONS
Brief Title
The Mechanism Versus PPI Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 89 years
- Chronic laryngeal symptoms such as cough, throat clearing, or voice changes lasting 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 medications
- History of foregut surgery
- Diagnosis of achalasia
- Unable to fast for 4 hours
- Current tobacco use
- Pregnant or breastfeeding
- Unable to consent in English or Spanish without a legal guardian
- Imprisoned individuals
- Endoscopic findings showing esophageal mucosal abnormalities
- Unable to complete reflux monitoring
- Use of acid suppression 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
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 30 days before clinical upper endoscopy with reflux testing
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - 8 weeks
Participants receive an 8-week intervention involving proton pump inhibitor therapy or placebo combined with laryngeal recalibration therapy or lifestyle counseling, depending on their assigned strategy. Treatment visits include assessments like acoustics, aerodynamics, symptom surveys, saliva sampling, and physiologic measures.
3 in-person intervention visits at weeks 1, 4, and 8; plus weekly online surveys
Duration - Immediately after week 8 intervention visit
After completing the 8-week treatment, participants are informed of their assigned strategy and medication, then transitioned back to clinical care.
No additional study visits
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
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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