Mechanism-guided treatment versus proton-pump inhibitor therapy for chronic throat symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults referred for evaluation of laryngopharyngeal reflux (LPR) who undergo endoscopy and ambulatory reflux monitoring off acid suppression are randomized 1:1 to a mechanism-guided strategy or to usual-care PPI therapy in an 8-week blinded phase. The mechanism-guided arm personalizes use of acid suppression and provides laryngeal recalibration/voice therapy plus GERD lifestyle advice, while the usual-care arm receives standard PPI-based management (omeprazole 40 mg or matched placebo during the blinded phase). Primary comparison is the proportion of participants achieving a predefined symptom response after the intervention period. Participants are assessed with baseline clinical testing and follow-up visits at the study site in San Diego.

Why it matters

Who can join: the full rules

Inclusion 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.

Exclusion Criteria:

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

Where it's running

• University of California San Diego
  San Deigo, California, United States Recruiting

Study contacts

• Principal investigator: Rena Yadlapati, MD — UC San Diego Health
• Study coordinator: Lorijane Robles
• Email: esophagealresearch@health.ucsd.edu
• Phone: 858-246-5236

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.