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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 89
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
University of California San Diego
RECRUITING
San Deigo
Contact Information
Primary
Lorijane Robles
esophagealresearch@health.ucsd.edu
858-246-5236
Time Frame
Start Date: 2025-06-04
Estimated Completion Date: 2029-07-01
Participants
Target number of participants: 160
Treatments
Active_comparator: Mechanism Guided Strategy
1\) 8-week course of double dose PPI or placebo; 2) Laryngeal Recalibration Therapy (LRT) with speech language pathologist (SLP). Subjects will receive PPI if their reflux monitoring is consistent with GERD and placebo if it is not consistent with GERD. SLP will administer LRT: LRT utilizes therapies that SLPs standardly utilize (mechanical and cognitive guidance) in combination specifically designed to treat laryngeal symptoms.~1. Mechanical Guidance: The SLP will guide subjects through laryngeal suppression, changing voice production, and improving breath coordination.~2. Cognitive Guidance: The SLP will guide subjects through relaxation and conceptualization changes.~3. Lifestyle Recommendations: In addition to receiving LRT, subjects will be counseled on typical lifestyle recommendations for GERD, detailed in the Usual Care Strategy below.
Active_comparator: Usual Care Strategy
1\) an 8-week course of double dose PPI and 2) lifestyle counseling. This represents the control group receiving usual care and will serve as the study's active control group. In order to maintain group concealment, subjects will receive counseling from a study investigator on standard lifestyle modifications recommended for GERD at intervals mirroring that of the mechanism guided strategy: week 1, week 4, and week 8 which is also reflective of standard recommended follow-up and counseling in GERD management.
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: University of California, San Diego

This content was sourced from clinicaltrials.gov