REVerse Intestinal Metaplasia in the Stomach (REVISE) (REVISE)

Therapeutic Intervention to Reverse Gastric Precancer

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.

Study Overview

• Status: Recruiting
• Conditions: Gastric Intestinal Metaplasia; Gastric Precancer
• Intervention / Treatment: Drug: Placebo; Drug: Pyrvinium

Detailed Description

The proposed study is an early Phase II Clinical Trial designed to generate additional data regarding safety and efficacy for the use of Pyrvinium, an FDA-approved drug no longer in active use. The study design includes enrollment in an observational cohort for a research-focused screening upper endoscopy to document the extent and type of gastric intestinal metaplasia in patients previously diagnosed with this condition using a standardized mapping protocol (as described below). This initial screening research endoscopy is needed as current clinical care is variable (due to lack of guidelines for mapping and surveillance). The investigators anticipate enrolling 60 participants in the observational cohort for intensive gastric mapping, and then of these 60 participants, 32 eligible participants (after determining eligibility based on presence of high-risk features of the gastric intestinal metaplasia with confirmed extensive gastric intestinal metaplasia) will be included in the randomized control trial to receive either Pyrvinium (n=16) or placebo (n=16).

Treatment is planned as followed:

2 weeks of Pyrvinium vs placebo (within 3 months of initial research endoscopy).

Following the initial endoscopy, participants will receive placebo or Pyrvinium (2 mg/kg/day) by mouth once each day for a total of 14 days. The drug (or placebo) will be verified and dispensed from the investigational drug pharmacy using an IND with attention to safety and blinding to research participants and clinical research staff. The drug and placebo will be administered as liquid suspensions. Medication diary logs will be used and participants will be asked to return bottles that contained the medication.

All participants will be advised to use sunblock and wear protective clothing due to potential for sun-sensitivity.

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Laura Hayes, MS; Phone Number: 919-684-8771; Email: laura.hayes@duke.edu
• Study Contact Backup: Name: Nicole Pavlus; Phone Number: 919-684-0311; Email: nicole.pavlus@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke Health
      • Contact: Christy Walters, RN; Phone Number: 919-668-5499; Email: christy.walters@duke.edu
      • Principal Investigator: Katherine Garman, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pyrvinium; Participants will receive Pyrvinium (2 mg/kg/day) by mouth once each day for a total of 14 days.	Drug: Pyrvinium; Pyrvinium (2 mg/kg) per day for 14 days
Placebo Comparator: Placebo; Participants will receive placebo by mouth once each day for a total of 14 days.	Drug: Placebo; Placebo for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the number of clinical biopsies with evidence of gastric intestinal metaplasia	For the efficacy analysis, the investigators will primarily evaluate the change in the number of clinical biopsies with evidence of gastric intestinal metaplasia from the screening endoscopy to the follow-up endoscopy.	Screening endoscopy (baseline) to the follow-up endoscopy (4-8 weeks)

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of clinical biopsies with evidence of gastric intestinal metaplasia	1 year
Number of clinical biopsies with complete gastric intestinal metaplasia	1 year
Number of clinical biopsies with incomplete gastric intestinal metaplasia	1 year
Number of clinical biopsies with presence of parietal cells (reversal of atrophy)	1 year
Number of clinical biopsies with presence of inflammation	1 year

Collaborators and Investigators

• Sponsor: Katherine Garman
• Investigators: Principal Investigator: Katherine Garman, MD, Duke Health

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: September 9, 2024
• First Submitted That Met QC Criteria: September 9, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Gastric Intestinal Metaplasia; Pyrvinium
• Additional Relevant MeSH Terms: Pathologic Processes; Metaplasia; Anti-Infective Agents; Antiparasitic Agents; Anthelmintics; pyrvinium
• Other Study ID Numbers: Pro00115397; CA230416P2 (Other Grant/Funding Number: Department of Defense)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No