NCT06378398

A Trial of Omeprazole and Low Dose Aspirin to Identify Colorectal Biomarkers of Preventive Efficacy

An Early Phase 1 Trial of Omeprazole and Low Dose Aspirin to Identify Colorectal Biomarkers of Preventive Efficacy: The Omeprazole and Aspirin Polyp Prevention Study

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This trial will obtain biomarker data on the possible preventive effects of omeprazole and low-dose aspirin in colorectal tissue. Persons who have had 5 or more adenomas, 5 or more serrated polyps, or an incompletely removed adenoma or serrated polyp in the colon or rectum are potentially eligible. Before participating in the study, study staff will explain the study and review the consent form. If you are interested and provide consent, study staff will then confirm your eligibility. Once enrolled, participants will take two 20 mg omeprazole tablets and two 81 mg aspirin tablets each day before the first meal each day for 25-45 days. The study does involve biopsies of the colorectal tissue before and after taking the study medications. The biopsies are samples of tissue, about the size of a grain of rice, that will be taken from the colon or rectum before and after taking the study medications. This is done during a usual, clinical colonoscopy exam and during one more limited exam, called flexible sigmoidoscopy, that is done for the research study. The flexible sigmoidoscopy requires less preparation. Which procedure comes first depends on what fits best with each participant's clinical scenario. Biopsies of both normal mucosa and polyps (if possible) are collected.

Detailed description

JAN2025 amendment added Adenomatous polyps meeting criteria for colon polyposis of unknown etiology (\> 20 lifetime adenomas)

Conditions

• Colorectal Neoplasia

Interventions

Type	Name	Description
DRUG	Omeprazole	Two 20 mg/day omeprazole tablets taken before the first meal each day for 25-45 days.
DRUG	Aspirin	Two 81 mg/day aspirin tablets taken before the first meal each day for 25-45 days.

Timeline

• Start date: 2024-06-14
• Primary completion: 2026-02-17
• Completion: 2026-02-17
• First posted: 2024-04-22
• Last updated: 2026-03-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study