REVerse Intestinal Metaplasia in the Stomach (REVISE)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorKatherine Garman
About this trial
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
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Pyrvinium
- Placebo
Treatment groups
32 Participants
are divided into 2 treatment groupsSponsors and collaborators
Katherine Garman
Lead sponsor
Duke University
Sponsor institution
Source ClinicalTrials.gov