Omeprazole + Lifestyle Therapy for Laryngopharyngeal Reflux

(MVP Trial)

Overseen By Lorijane Robles

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of California, San Diego

Must not be taking: Acid suppressants

Disqualifiers: Foregut surgery, Achalasia, Tobacco, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

160 Participants Needed

Trial Summary

What is the purpose of 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

Research Team

Rena Yadlapati, MD

Principal Investigator

UC San Diego Health

Eligibility Criteria

Adults aged 18-89 with chronic throat symptoms like cough, hoarseness, and acid reflux, who have been off acid suppression therapy for at least two weeks. They must be undergoing standard evaluation for LPR including an EGD and reflux monitoring.

Inclusion Criteria

I am between 18 and 89 years old.

I haven't taken acid suppression medication for at least 2 weeks.

I have had symptoms like coughing or voice changes for more than 8 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo an 8-week blinded study phase with randomization to either Mechanism Guided Strategy or Usual Care Strategy, including taking an oral capsule daily and attending 3 in-person visits.

8 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including transitioning back to clinical care.

4 weeks

Treatment Details

Interventions

• Omeprazole

Trial Overview The trial is testing a new multidisciplinary approach called Mechanism Guided Strategy against the usual care strategy involving PPI therapy (Omeprazole). Participants will take part in an 8-week study phase with random assignment to one of these strategies.

Participant Groups

Group I: Usual Care Strategy Active Control 2 Interventions

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.

Group II: Mechanism Guided Strategy Active Control 3 Interventions

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.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+