Health Trials

The Mechanism Versus PPI Trial

ConditionsLaryngopharyngeal RefluxCoughThroat ClearingDysphoniaReflux
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-89
SponsorUniversity of California, San Diego

About this 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 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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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)

Trial design

Treatments tested in this trial

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

Treatment groups

160 Participants
are divided into 2 treatment groups

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

University of California San DiegoRecruiting92093, San Deigo, CaliforniaUnited StatesUnited States

Sponsors and collaborators

University of California, San Diego

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov