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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

H Pylori Infection Digestive System Diseases Digestive System Neoplasms Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms H Pylori Gastritis Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PYTEST® 14C-Urea Breath Test

Drug

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.

Primary outcomes

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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

NRG Oncology
Phathom Pharmaceuticals

Registry information

Important dates

Study start: 2022
Primary completion: 2027
Study completion: 2027
First posted: Nov 3, 2025
Registry last updated: Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting