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.

Study Overview

• Status: Active, not recruiting
• Conditions: Gastric Cancer; H Pylori Infection; H Pylori Gastritis
• Intervention / Treatment: Drug: PYTEST® 14C-Urea Breath Test; Drug: VOQUEZNA® Triple Pak®

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Helicobacter Pylori Screening and Treatment; Participants in this single-arm study will undergo screening for Helicobacter pylori (H. pylori) using the PYtest® 14C-Urea Capsule Breath Test. This FDA-approved, non-invasive diagnostic method involves swallowing a radiolabeled urea capsule. If gastric urease from H. pylori is present, the urea is hydrolyzed to produce carbon dioxide and ammonia. Ten minutes after ingestion, a breath sample is collected in a balloon and transferred into a collection fluid to trap the labeled carbon dioxide. The sample is analyzed using a liquid scintillation counter to determine infection status. Participants who test positive will receive VOQUEZNA® Triple Pak® therapy, dispensed by the study team at the time of diagnosis. Phathom Pharmaceuticals will supply the medications (which include complete medication package insert), but the study team hold and dispenses medications.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: NRG Oncology; Phathom Pharmaceuticals
• Investigators: Principal Investigator: Shria Kumar, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2022
• Primary Completion (Estimated): November 6, 2027
• Study Completion (Estimated): November 6, 2027

Study Registration Dates

• First Submitted: October 30, 2025
• First Submitted That Met QC Criteria: October 30, 2025
• First Posted (Actual): November 3, 2025

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: 20211207-AIM 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No