RecruitingPhase 2NCT06590454

REVerse Intestinal Metaplasia in the Stomach (REVISE)

Therapeutic Intervention to Reverse Gastric Precancer


Sponsor

Katherine Garman

Enrollment

32 participants

Start Date

Dec 15, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria3

  • 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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Interventions

DRUGPyrvinium

Pyrvinium (2 mg/kg) per day for 14 days

DRUGPlacebo

Placebo for 14 days


Locations(1)

Duke Health

Durham, North Carolina, United States

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NCT06590454


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