REVerse Intestinal Metaplasia in the Stomach (REVISE)

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Katherine Garman
Study ID
NCT06590454
Phase
PHASE2
Status
Recruiting
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Conditions

  • Gastric Intestinal Metaplasia
  • Gastric Precancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pyrvinium — DRUG
    Pyrvinium (2 mg/kg) per day for 14 days
  • Placebo — DRUG
    Placebo for 14 days

Study Details

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.

Key Dates

Start date
Dec 15, 2025
Status verified
Feb 2026
Primary completion
Oct 1, 2026
Completion
Oct 1, 2026

Study Design

Enrollment
32 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Pyrvinium
    Participants will receive Pyrvinium (2 mg/kg/day) by mouth once each day for a total of 14 days.
  • Placebo Comparator: Placebo
    Participants will receive placebo by mouth once each day for a total of 14 days.

Primary Outcome Measure

Change in the number of clinical biopsies with evidence of gastric intestinal metaplasia [ Time Frame: Screening endoscopy (baseline) to the follow-up endoscopy (4-8 weeks) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke HealthDurhamNorth Carolina27710
Christy Walters, RN
[email protected]
919-668-5499
Katherine Garman, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Duke Health· Durham, NC

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