Recruiting
Phase 4

PPI with CYP2C19

Sponsor:

University of Florida

Code:

NCT07843264

Conditions

Gastroesophageal Reflux Disease With Esophagitis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

CYP2C19 based dosing Proton Pump Inhibitors

Conventional proton pump inhibitor dose

Study Details

Brief summary:

This study is being done to determine if the dosing of proton pump inhibitor (PPI) medication based on CYP2C19 genotype-derived phenotype leads to improved healing of erosive esophagitis compared to conventional PPI medication dosing.

Conditions

Gastroesophageal Reflux Disease With Esophagitis

Study ID

NCT07843264

Start date

Nov 1, 2026

Status verified date

Jul, 2026

Completion date

Apr 1, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • age ≥ 18 years
  • diagnosis of Gastroesophageal Reflux Disease (GERD) scheduled for an esophagogastroduodenoscopy (EGD)
  • patients diagnosed with Erosive Esophagitis on endoscopy (EGD).

Exclusion Criteria:

  • age <18 years
  • diagnosed with non-erosive reflux disease (NERD)
  • pregnancy

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention

proton pump inhibitor dose based on CYP2C19 phenotypes

active comparator: Control

conventional proton pump inhibitor dose of Pantoprazole 40 mg once or twice daily

Interventions

CYP2C19 based dosing Proton Pump Inhibitors

Pantoprazole dosing based on CYP2C19 phenotypes

Conventional proton pump inhibitor dose

conventional PPI dose of Pantoprazole 40 mg once or twice daily

Primary outcome measure

  • Improvement of Los Angeles (LA) classification of Erosive Esphagitis (EE) grade [ Time Frame: 8 weeks ]

Central Contacts and Locations

Locations

UF Health

Recruiting

Jacksonville, Florida, United States, 32209

Contacts

Ruchir Puri, MD

904-244-7327ruchir.puri@jax.ufl.edu

Principal Investigator:

Ruchhir Puri, MD

More Information

Sponsor

University of Florida

Last update posted

Nov 12, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-13. This information was provided to ClinicalTrials.gov by University of Florida on 2026-11-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.