RECRUITING

The Mechanism Versus PPI Trial

Description

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

Study Overview

Study Details

Study overview

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

The MVP Trial: A Randomized Controlled Trial of Mechanism Guided vs PPI Strategy for Laryngopharyngeal Reflux

The Mechanism Versus PPI Trial

Condition
Laryngopharyngeal Reflux
Intervention / Treatment

-

Contacts and Locations

San Deigo

University of California San Diego, San Deigo, California, United States, 92093

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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

Ages Eligible for Study

18 Years to 89 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of California, San Diego,

Rena Yadlapati, MD, PRINCIPAL_INVESTIGATOR, UC San Diego Health

Study Record Dates

2029-07-01