REVerse Intestinal Metaplasia in the Stomach (REVISE) (NCT06590454) | Clinical Trial Compass
RecruitingPhase 2
REVerse Intestinal Metaplasia in the Stomach (REVISE)
United States32 participantsStarted 2025-12-15
Plain-language summary
This study is designed to test the use of Pyrvinium vs placebo as a treatment for gastric intestinal metaplasia with features associated with increased risk of cancer. Response will be determined by assessing the extent and quality of the gastric intestinal metaplasia before and after treatment.
A secondary aim will be to generate gastric organoids from patient-derived samples to test the effects of pyrvinium in vitro in patient-derived samples, and also to identify new drugs that may help reverse gastric intestinal metaplasia.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults (including men, women, and non-binary individuals) over age 18 with known GIM with at least one high-risk feature (extensive vs limited, incomplete or mixed-type GIM, family history of stomach cancer),
* Ability to provide informed consent,
* Evidence of prior but not active H. pylori infection
Exclusion Criteria:
* Active gastric cancer diagnosis,
* High-risk of bleeding complications due to anticoagulants or underlying medical condition,
* Pregnancy (which is a contraindication to non-emergent endoscopy due to anesthesia risks)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically trying to reverse gastric intestinal metaplasia — does my diagnosis and biopsy pattern make me a good candidate to discuss this study with my care team?
2Since this is a Phase 2 trial, what do we know so far about the safety of whatever treatment is being tested here, and what uncertainties still exist that I should weigh before considering enrollment?
3The trial measures whether the number of biopsies showing intestinal metaplasia actually decreases — how would that be tracked in me, and how many follow-up biopsies or endoscopies would I likely need to undergo?
4Is there a standard monitoring or treatment approach for gastric intestinal metaplasia that I should consider first, or is participating in a study like this something worth discussing as an alternative or complement to that?
5If my intestinal metaplasia doesn't respond during the trial, would I still have access to the same treatment options I'd have if I never joined, and how would we know early enough to make that call?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in the number of clinical biopsies with evidence of gastric intestinal metaplasia
Timeframe: Screening endoscopy (baseline) to the follow-up endoscopy (4-8 weeks)