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ACTIVE NOT RECRUITING
NCT07224035
PHASE4

Helicobacter Pylori Screening and Treatment in the At-risk South Florida Community- AIM 1

Sponsor: University of Miami

View on ClinicalTrials.gov

Summary

H. pylori is an infection of the stomach that can cause chronic gastritis, gastric cancer and peptic ulcer disease. The goal of this study is to screen people for this infection and offer treatment for those who test positive for the infection. By treating those who are positive for H. pylori, there is an opportunity to prevent gastritis, peptic ulcer disease, and even gastric cancer.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2022-10-15

Completion Date

2027-11-06

Last Updated

2026-02-17

Healthy Volunteers

Yes

Interventions

DRUG

PYTEST® 14C-Urea Breath Test

FDA-approved radiolabeled urea capsule used in the PYtest® 14C-Urea Breath Test for non-invasive detection of H. pylori. Participants ingest the capsule, and breath samples are collected and analyzed to determine infection status.

DRUG

VOQUEZNA® Triple Pak®

FDA-approved combination therapy for H. pylori infection, consisting of: Vonoprazan tablets 20 mg (1 tablet twice daily for 14 days) Amoxicillin 500 mg (2 tablets twice daily for 14 days) Clarithromycin 500 mg (1 tablet twice daily for 14 days) Medications are dispensed by the study team at the time of diagnosis.

Locations (1)

University of Miami

Miami, Florida, United States