RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2023-03-14
Study Completion:2024-12-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05799105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subjects diagnosed with marginal ulceration post-gastric bypass on upper endoscopy
  1. * Refusal to start PPI medication OR current open-capsule PPI use at the time of diagnosis of the marginal ulcer

Contacts and Locations

Study Contact

C. Roberto Simons-Linares, MD
CONTACT
216-444-8460
bariatricendoscopy@ccf.org

Principal Investigator

C. Roberto Simons-Linares, MD
PRINCIPAL_INVESTIGATOR
Assistant Professor

Study Locations (Sites)

Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: Carlos Roberto Simons-Linares

  • C. Roberto Simons-Linares, MD, PRINCIPAL_INVESTIGATOR, Assistant Professor

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-14
Study Completion Date2024-12-23

Study Record Updates

Study Start Date2023-03-14
Study Completion Date2024-12-23

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Marginal Ulcer