Pyrvinium for the Treatment of Gastric Intestinal Metaplasia in Patients Previously Treated for Helicobacter Pylori Infection, REVISE Trial

Inclusion Criteria

• INITIAL SCREENING PHASE: 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)
• INITIAL SCREENING PHASE: Ability to provide informed consent
• INITIAL SCREENING PHASE: Evidence of prior but not active H. pylori infection
• RANDOMIZED CONTROL TRIAL: Based upon histology results as well as demographic factors, we will select participants who meet eligibility criteria (confirmed presence of extensive gastric intestinal metaplasia defined by metaplasia in both gastric antrum/incisura and gastric body) for the randomized control trial

Exclusion Criteria

• INITIAL SCREENING PHASE: No engagement in other clinical trials with interventions in the three months prior to enrollment
• INITIAL SCREENING PHASE: Conditions that confer increased risk associated with endoscopy and biopsies such as high-risk of bleeding complications due to anticoagulants or underlying medical condition are exclusions for this study
• INITIAL SCREENING PHASE: No active gastric cancer diagnosis at the time of enrollment or at screening
• INITIAL SCREENING PHASE: As there are limited data available regarding the use of repeat doses of the study drug for 14 days, this phase II study will also exclude those with active inflammatory bowel disease, uncontrolled diabetes, diagnosis of chronic kidney disease or known renal impairment with estimated reduction in glomerular filtration rate (GFR) < 90 mL/min/1.73 m^2
• INITIAL SCREENING PHASE: Exclusions related to underlying liver disease are evidence of cirrhosis or transaminitis (aspartate aminotransferase [AST] and/or alanine aminotransferase [ALT] > 2x the upper limit of normal or total bilirubin > 2x the upper limit of normal). Other exclusions include seizure disorder, chronic neurologic or psychiatric conditions that may impact the ability to complete all study assessments
• INITIAL SCREENING PHASE: Ongoing regular alcohol consumption that is > 2 drinks / day for males and > 1 drink / day for females is an exclusion for enrollment and participants who meet enrollment criteria will be advised not to exceed these thresholds during the period of drug administration and in the 30 days following
• INITIAL SCREENING PHASE: Pregnancy (which is a contraindication to non-emergent endoscopy due to anesthesia risks) is an exclusion at enrollment; female participants of childbearing age must have a negative pregnancy test prior to each endoscopy and within 30 days prior to study entry and must use one form of highly effective beginning one month prior to initiation of the study drug continuing until 30 days after the last dose of the study drug. Highly effective methods of contraception are defined as those, alone or in combination, that result in a low failure rate (i.e., less than 1 percent per year) when used consistently and correctly