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 range18 Years

SexALL

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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)

What they're measuring

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)

Trial details

NCT IDNCT06590454

SponsorKatherine Garman

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10-01

Contact for this trial

Nicole Pavlus

919-684-0311 nicole.pavlus@duke.edu

View on ClinicalTrials.gov More Gastric Intestinal Metaplasia trials