PPI Dosing Per CYP2C19 Genotype

September 23, 2026 updated by: University of Florida

A Pilot Study to Assess Healing of Erosive Esophagitis in Patients Randomized to Conventional PPI Doses Versus Dosing Based on CYP2C19 Genotype

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention

proton pump inhibitor dose based on CYP2C19 phenotypes
Drug: CYP2C19 based dosing Proton Pump Inhibitors

Pantoprazole dosing based on CYP2C19 phenotypes
Active Comparator: Control

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

conventional PPI dose of Pantoprazole 40 mg once or twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of Los Angeles (LA) classification of Erosive Esphagitis (EE) grade
Time Frame: 8 weeks

Assessment of erosive esophagitis grade to determine healing in both arms. Healing would be measured by endoscopic regression of errosive esophagitis (EE) to a lower degree of inflammation. Previously assigned baseline numerical values per the LA classification of EE will be used to calculate the degree of healing in each arm at the 8th week follow up, e.g. LA grade D (initial EGD) to LA grade A (repeat EGD) would yield a score of 3 (LA D [5] - LA A [2]). A higher score hence indicating superior healing of EE.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

  • Principal Investigator: Ruchir Puri, MD, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

September 11, 2026

First Submitted That Met QC Criteria

September 23, 2026

First Posted (Actual)

September 28, 2026

Study Record Updates

Last Update Posted (Actual)

September 28, 2026

Last Update Submitted That Met QC Criteria

September 23, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB202600862

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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