Clinical trial Recruiting at 1 site Phase 4 Interventional

Comparing two ways of taking acid-blocking medications for stomach ulcers after gastric bypass surgery

Official title: OPEN Versus InTact Capsule Proton Pump Inhibitors for the Treatment of Marginal Ulcers After Bariatric Surgery

Run by The Cleveland Clinic · NCT05799105 · Data updated 2026-11-12

This study is testing whether taking acid-blocking medication for stomach ulcers in an open capsule form works better than taking it in a whole capsule for people who have had gastric bypass surgery.

Quick facts

PhasePhase 4
Study typeInterventional
SexAll
Enrollment122 (estimated)
SponsorThe Cleveland Clinic
Academic / other
Locations1 site (Cleveland, Ohio)
StatusRecruiting
StartedMarch 14, 2023
Main results expectedMarch 23, 2027
Study endsMarch 23, 2027
Registry record updatedMarch 19, 2026
Trial IDNCT05799105 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are patients diagnosed with marginal ulcers following gastric bypass surgery.

Probably not a fit

Patients who are currently using open-capsule PPIs or refuse to start PPI medication will not benefit from this study.

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

What this trial studies

This clinical trial aims to determine the effectiveness of taking proton pump inhibitors (PPIs) in two different forms: as an open capsule versus an intact capsule for treating marginal ulcers in patients who have undergone gastric bypass surgery. Participants diagnosed with marginal ulcers will be instructed to take either the contents of the capsule or the whole capsule, with their healing monitored through regular upper endoscopies. The study seeks to assess whether the open-capsule method leads to better healing outcomes and fewer complications compared to the traditional method. This is the first trial of its kind to explore this approach in this patient population.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with marginal ulcers, potentially reducing complications and the need for additional procedures.

How similar studies have gone: This approach is novel and has not been previously tested in clinical trials for this specific patient population.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Cleveland Clinic Foundation
    Cleveland, Ohio, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.