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

Phase 4Active Not RecruitingNCT07224035

University of Miami500 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

500

Conditions

H Pylori Infection H Pylori Gastritis Gastric Cancer

Interventions

PYTEST® 14C-Urea Breath TestDRUG

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.

VOQUEZNA® Triple Pak®DRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Adults ≥ 18 years of age Exclusion Criteria: * Adults with a personal history of gastric cancer * Adults with prior history of H. Pylori (HP) treatment and confirmed eradication * Adults unable to consent * Adults unable to consent in their preferred language * Pregnant women, those who are breastfeeding, or those who are planning to become pregnant/breastfeed * Prisoners * Persons who are allergic, hypersensitive, or unable to take any of the components of the medication regimen VOQUEZNA® Triple Pak®: * vonoprazan * amoxicillin or any other beta-lactams (e.g. penicillins and cephalosporins) * clarithromycin or any other macrolide antimicrobial (e.g. erythromycin) * Persons presently taking any of the following: * Rilpivirine-containing products * Pimozide * Lomitapide, lovastatin, simvastatin, atorvastatin, and pravastatin * Ergot alkaloids * Colchicine (if with kidney or liver impairment) * Lurasidone * Drugs known to prolong the QT interval (e.g., pimozide). * Class IA (e.g., quinidine, procainamide, disopyramide) or Class III (e.g., dofetilide, amiodarone, sotalol) antiarrhythmic agents * Verapamil, amlodipine, diltiazem, nifedipine * Nateglinide, pioglitazone, repaglinide, rosiglitazone, and insulin * Quetiapine * Warfarin * Benzodiazepines (e.g. triazolam, midazolam) * Persons who have any of the following, as they may be prone to adverse effects from the medication regimen: * History of cholestatic jaundice * Severe kidney impairment * Severe hepatic impairment * Participants with known prolongation of QT interval, ventricular cardiac arrhythmia, including torsades de pointes. * Participants with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia * Participants with ongoing mononucleosis

Locations (1)

University of Miami

Miami, Florida, United States

Outcomes

Primary Outcomes

Percent of participants diagnosed with Helicobacter pylori using PYTEST® breath test at baseline

This measure determines the percent of participants who test positive for Helicobacter pylori at baseline. This is done using the PYTEST® 14C-Urea Breath Test. Participants will receive a diagnosis on-site, approximately 30 minutes after administration of urea capsule. This will allow immediate treatment free of charge (VOQUEZNA® Triple Pak®) initiation for positive eligible participants.

Time frame: Baseline

Data from ClinicalTrials.gov

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