Comparing two ways of taking acid-blocking medications for stomach ulcers after gastric bypass surgery
OPEN Versus InTact Capsule Proton Pump Inhibitors for the Treatment of Marginal Ulcers After Bariatric Surgery
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
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 122 (estimated) |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT05799105 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with marginal ulcers following gastric bypass surgery.
Not a fit: Patients who are currently using open-capsule PPIs or refuse to start PPI medication will not benefit from this study.
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 performed: This approach is novel and has not been previously tested in clinical trials for this specific patient population.
Eligibility criteria
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 this trial is running
Cleveland, Ohio
- Cleveland Clinic Foundation — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Stephen Firkins, MD — The Cleveland Clinic
- Study coordinator: Stephen Firkins, MD
- Email: bariatricendoscopy@ccf.org
- Phone: 216-444-8460
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.