Efficacy of Potassium-Competitive Acid Blockers in Barrett's Esophagus (PCAB BE Study)

NCT07788742 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: 25-2665
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This is a research study to look at how a new medication compares to standard treatment for reducing acid reflux in patients with Barrett's Esophagus. The study drug is Vonoprazan. This is a pill that is not yet FDA-approved for this purpose in this patient population. The participants will first continue their current acid-reducing medicine (PPI) once a day for at least 7 days. After that, they will have a test to measure acid levels in their esophagus (food tube) while still taking the PPI medication. After this test, they will stop their current PPI medication and start taking the study drug, Vonoprazan, once a day for 7-28 days. They will then have a second acid test while on the study drug (Vonoprazan). Before each test, the participants will complete a short questionnaire about their symptoms. The study team will collect their health history, including medical conditions and current medications. After they finish the study drug, they will have a follow-up visit in about 30 days. The participation in the study will then end.

Conditions

Barrett Esophagus

Keywords

barrett esophagus

Outcome Measures

Primary Outcomes (1)

• Difference in percent time with pH<4 during 24-hour pH monitoring on PPI and PCAB therapies. (Normal is <4.0%)

  24 hour pH impedance testing is a routine clinical care procedure that is often conducted in this patient population as part of their ongoing care and maintenance of their condition to analyze reflux events. The test is minimally invasive. Participant's esophageal pH level is measured by completing 24 hour impedance test on visits 2 and 3. The participants will be on PPI during their first impedance test and they will be on vonoprazan during their second impedance test. The findings of this test will be used to calculate the difference in percent time with pH\<4 during 24-hour pH monitoring.

  Visit 2 (1 day after Baseline through 1 day prior to PCAB switch), Visit 3 (7-28 days after switching to PCAB)

Secondary Outcomes (3)

• Difference in reflux symptom severity scores as measured by the GERD-HRQL questionnaire.

  Visit 2 (1 day after Baseline through 1 day prior to PCAB switch), Visit 3 (7-28 days after switching to PCAB)

• Difference in percent time with pH<5 during 24-hour pH monitoring.

  Visit 2 (1 day after Baseline through 1 day prior to PCAB switch), Visit 3 (7-28 days after switching to PCAB)

• Difference in mean pH during 24-hr pH monitoring.

  Visit 2 (1 day after Baseline through 1 day prior to PCAB switch), Visit 3 (7-28 days after switching to PCAB)

Study Arms (1)

Proton Pump Inhibitors (PPI) to Potassium-Competitive Acid Blockers (PCABs)

OTHER

All participants will be enrolled while receiving PPI. After participant has been on a once daily PPI therapry regimen for at least 7 days, a 24-hour ph impedance test will be conducted while still receiving PPI medication. Participants will then be switched to PCABs for 7-28 days. A second 24-hour ph impedance test will be conducted by Day 28 while participants are taking PCABs.

Drug: Potassium-Competitive Acid Blockers (PCABs)

Interventions

Potassium-Competitive Acid Blockers (PCABs) DRUG

Potassium -competitive acid blockers (PCABs) are a newer class of acid-suppressing medications more potent than PPIs, with a faster onset and longer duration of action. PCABs are FDA-approved.

Proton Pump Inhibitors (PPI) to Potassium-Competitive Acid Blockers (PCABs)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 or older at time of consent.
• Able to read and understand English and provide written informed consent.
• History of Gastroesophageal Reflux Disease (GERD) with or without heartburn.
• Diagnosed with nondysplastic Barrett's Esophagus (NBDE) defined as meeting the following within the past 3 years:
• Endoscopically confirmed BE with segment length ≥2 cm (to avoid those with an irregular Z line), and
• Histologic evidence of intestinal metaplasia without dysplasia ("dysplasia" includes indefinite for dysplasia).
• Currently on proton pump inhibitor (PPI) maintenance therapy, defined as PPI prescribed once or twice daily for 3 or more months (defined as 90 days or more) from consent. Any formulation and dosage of PPI will be included, including pantoprazole, omeprazole, esomeprazole, lansoprazole, rabeprazole, dexlansoprazole or their generic equivalents.
• If currently on twice daily PPI, then able to modify PPI regimen to once daily dosing as part of their routine clinical care.
• Ability to take oral medication and willing to adhere to study intervention regimen.
• Willing to follow lifestyle recommendations as outlined in protocol section 5.3

You may not qualify if:

• Barrett's Esophagus (BE) with dysplasia (indefinite for dysplasia, or low-grade dysplasia, or high-grade dysplasia) diagnosed within 12 months of study entry.
• Current or prior esophageal adenocarcinoma (EAC).
• Use of other acid suppressive medications.
• H. pylori diagnosis or treatment within the past 6 months prior to study entry.
• History of upper gastrointestinal tract surgery (e.g., esophagectomy or surgery for reflux disease).
• Current contraindication to 24hr pH impedance test, including:
• Recent broken nose, nasal surgery, or known deviated septum; or
• Bleeding disorders or those taking certain blood-thinning medications and unable to temporarily discontinue use per current clinical guidance may also be excluded due to increased risk of bleeding during catheter insertion; or
• Individuals with implanted devices like pacemakers or defibrillators.
• Known hypersensitivity or allergic reaction to any component of the study intervention.
• Treatment with another investigational product within 30 days prior to consent.
• Current use of rilpivirine-containing products.
• Pregnant, breastfeeding, or considering becoming pregnant or intending to donate ova during the study and for 30 days after the last dose of study drug.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Phathom Pharmaceuticals, Inc.: collaborator

Study Sites (1)

University of North carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Nicholas Shaheen, MD, MPH

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shilpa Karanjit, MPH

CONTACT

919-843-8519; shilpa_karanjit@med.unc.edu

Susan E Moist, MPH

CONTACT

919-918-5900; susan_moist@med.unc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: August 26, 2026
• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2029
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)