RECRUITING

The Mechanism Versus PPI Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2025-06-04
Study Completion:2029-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06999577

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.

Ages Eligible for Study:18 Years to 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. 18-89 years of age
  2. 2. \>8 weeks of laryngeal symptoms (cough, throat clearing, dysphonia)
  3. 3. Standard evaluation for LPR, undergoing EGD (with endoscopic evaluation of the hypopharynx) and reflux monitoring off acid suppression
  4. 4. Off acid suppression therapy for at least 2 weeks prior to randomization.
  1. 1. PPI intolerance and/or known hypersensitivity to the formulation or substituted benzimidazoles
  2. 2. History of foregut surgery
  3. 3. Known diagnosis of achalasia
  4. 4. Inability to fast for 4 hours (no food or drink)
  5. 5. Active tobacco use
  6. 6. Pregnant or breastfeeding
  7. 7. Unable to consent in English or Spanish
  8. 8. Unable to provide consent without a legal guardian or representative
  9. 9. Imprisoned
  10. 10. Endoscopic findings conclusive with esophageal mucosal abnormalities
  11. 11. Unable to proceed with reflux monitoring
  12. 12. Use of acid suppression during the reflux monitoring and/or before the study medication (omeprazole or placebo) is dispensed
  13. 13. Prior LRT for reflux related symptoms
  14. 14. History of major psychiatric comorbidity
  15. 15. Unable to attend in person study visits at UCSD

Contacts and Locations

Study Contact

Lorijane Robles
CONTACT
858-246-5236
esophagealresearch@health.ucsd.edu

Principal Investigator

Rena Yadlapati, MD
PRINCIPAL_INVESTIGATOR
UC San Diego Health

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of California, San Diego

  • Rena Yadlapati, MD, PRINCIPAL_INVESTIGATOR, UC San Diego Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-04
Study Completion Date2029-07-01

Study Record Updates

Study Start Date2025-06-04
Study Completion Date2029-07-01

Terms related to this study

Additional Relevant MeSH Terms

  • Laryngopharyngeal Reflux
  • Cough
  • Throat Clearing
  • Dysphonia
  • Reflux