Health TrialsbyHealthPanel

REVerse Intestinal Metaplasia in the Stomach (REVISE)

ConditionsGastric Intestinal MetaplasiaGastric Precancer
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Pyrvinium

    Drug

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

  • Placebo

    Drug

    Placebo for 14 days

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: PyrviniumActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Screening endoscopy (baseline) to the follow-up endoscopy (4-8 weeks)

Secondary outcomes

1

Number of clinical biopsies with evidence of gastric intestinal metaplasia

Time frame
1 year
2

Number of clinical biopsies with complete gastric intestinal metaplasia

Time frame
1 year
3

Number of clinical biopsies with incomplete gastric intestinal metaplasia

Time frame
1 year
4

Number of clinical biopsies with presence of parietal cells (reversal of atrophy)

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Katherine Garman

Lead sponsor

Duke University

Sponsor institution

Source ClinicalTrials.gov
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