The Mechanism Versus PPI Trial

ConditionsLaryngopharyngeal Reflux Cough Throat Clearing Dysphonia Reflux

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Omeprazole 40 MG
Drug
8 week double dose therapy of proton pump inhibitor or placebo.
Laryngeal Recalibration Therapy
Behavioral
LRT utilizes therapies that SLPs standardly utilize (mechanical and cognitive guidance) in combination specifically designed to treat laryngeal symptoms. Each session with the SLP will guide subjects through these therapies. The existing script-based LRT protocol consists of the following: 1) mechanical guidance (laryngeal suppression, voice production, breath coordination), 2) cognitive guidance (identification of thinking patterns, recalibration of thoughts about laryngeal sensations).
GERD Lifestyle Recommendations
Behavioral
This is the typical lifestyle recommendations for GERD used clinically.

Treatment groups

160 Participants

are divided into 2 treatment groups

Group A: Mechanism Guided StrategyActive comparator 3 interventions

Group B: Usual Care StrategyActive comparator 2 interventions

Trial outcomes

Primary outcomes

Symptom Response

Proportion of subjects with symptom response measured by the reflux symptom index (RSI) score.

Time frame

5 years

Secondary outcomes

Diagnostic Methods for LPR

Symptom response to PPI measured by the RSI score

Time frame

5 years

Locations

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

University of California San DiegoRecruiting92093, San Deigo, California

United States

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Diego

Lead sponsor

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

Collaborator

Source ClinicalTrials.gov

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