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Recruiting Phase 2 NCT06590454

REVerse Intestinal Metaplasia in the Stomach (REVISE)

Trial Parameters

Condition Gastric Intestinal Metaplasia
Sponsor Katherine Garman
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 32
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-12-15
Completion 2026-10-01
Interventions
PyrviniumPlacebo

Brief 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.

Eligibility Criteria

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)

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