OPEN Versus InTact Capsule Proton Pump Inhibitors for the Treatment of Marginal Ulcers

Study Overview
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Brief Summary
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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).

Detailed Description
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Marginal ulcers (ulcers formed at the surgery site between the stomach and the intestines) are a common complication of bariatric surgery, ranging in frequency from 0.6-25% of patients. Furthermore, roughly 17% of patients with marginal ulcers require repeat procedures or surgery for severe complications such as bleeding, perforation, stricture, and fistulas. Proton pump inhibitors (PPIs), which act by block acid secretion from the stomach, are the gold standard for treatment of ulcers. There is limited data showing that opening the PPI capsule and taking only the contents greatly improves healing of marginal ulcers after gastric bypass surgery. This is likely due to the much smaller stomach, faster passage through the stomach and decreased ability of the intact PPI medication to be broken down and absorbed. This would be the first clinical trial to confirm whether this is true, which would support all patients who get ulcers after gastric bypass surgery to be treated with open-capsule PPI medications.

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

Conditions
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Marginal Ulcer

Intervention / Treatment
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* Drug: Omeprazole 40 milligrams


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective single-blinded randomized control trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open-capsule<br>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. | Drug: Omeprazole 40 milligrams<br>* 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.<br>* Other names: Losec;|
| Active Comparator: Intact-capsule<br>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. | Drug: Omeprazole 40 milligrams<br>* 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.<br>* Other names: Losec;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ulcer healing | Rate of ulcer healing in each treatment arm, defined as resolution of previously-seen ulcer on upper endoscopy | On average, 3 months to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ulcer healing time | Time to ulcer healing, defined as (date of ulcer healing) - (date of ulcer diagnosis) | On average, 3 months to 12 months | 
| pH of gastric pouch | pH of the gastric pouch fluid will be obtained during initial endoscopy and tested with litmus paper. pH data will be compared between the two treatment arms. | Upon initial enrollment endoscopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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marginal ulcer, bariatric surgery, gastric bypass, open capsule