Recruiting

Proton-Pump Inhibitors

Sponsor:

Stephen Firkins

Code:

NCT05799105

Conditions

Marginal Ulcer

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Omeprazole 40 milligrams

Study Details

Brief summary:

The goal of this clinical trial is to identify the most effective way to take acid-blocking medications to treat stomach ulcers in patients who have undergone gastric bypass surgery. The main questions it aims to answer are:

  • is taking an acid-blocking medication by opening the capsule and only taking the contents of the capsule (open-capsule) more or less effective than taking the capsule as a whole (intact-capsule) for treating ulcers in patients who have a history of gastric bypass surgery?
  • does taking the open versus intact medication decrease the number of procedures and complications from untreated ulcers?

Participants with ulcers will be instructed to take acid-blocking medications (called proton-pump inhibitors) either by opening the capsule and taking only the contents or by taking the capsule whole. These medications are the gold standard for treatment of stomach ulcers. Participants will be asked to undergo an upper endoscopy (EGD) every 3 months to monitor the healing of the ulcers.

Researchers will compare how quickly the ulcers heal depending on which way the medications are taken (opened up or as a whole).

Conditions

Marginal Ulcer

Study ID

NCT05799105

Start date

Mar 14, 2023

Status verified date

Mar, 2026

Completion date

Mar 23, 2027

Anticipated

Primary completion date

Mar 23, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Subjects diagnosed with marginal ulceration post-gastric bypass on upper endoscopy

Exclusion Criteria:

  • Refusal to start PPI medication OR current open-capsule PPI use at the time of diagnosis of the marginal ulcer

Study Design

Enrollment

122 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Open-capsule

Subjects in this arm will be treated with omeprazole 40 milligrams twice daily (or alternative medication if not covered by the subject's insurance) taken as an open-capsule until confirmed ulcer healing.

active comparator: Intact-capsule

Subjects in this arm will be treated with omeprazole 40 milligrams twice daily (or alternative medication if not covered by the subject's insurance) taken as an intact-capsule until confirmed ulcer healing or potential cross-over.

Interventions

Omeprazole 40 milligrams

Subjects will be randomized to treatment with either open-capsule or intact-capsule omeprazole to assess effect on ulcer healing times. If interim analysis illustrates significantly improved healing in the open-capsule group, the control (intact-capsule) arm will be allowed to cross-over to open-capsule and be followed until confirmed ulcer healing.

Primary outcome measure

  • Ulcer healing [ Time Frame: On average, 3 months to 12 months ]

Central Contacts and Locations

Central contacts

Stephen Firkins, MD

216-444-8460bariatricendoscopy@ccf.org

Locations

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Stephen Firkins, MD

216-444-8460bariatricendoscopy@ccf.org

More Information

Sponsor

Stephen Firkins

Last update posted

Mar 19, 2026

Last verified

Mar, 2026

Keywords

  • marginal ulcer
  • bariatric surgery
  • gastric bypass
  • open capsule

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stephen Firkins on 2026-03-19.