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

NCT07224035 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: 20211207-AIM 1
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

H Pylori Infection; H Pylori Gastritis; Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Helicobacter Pylori Screening and Treatment

EXPERIMENTAL

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; Drug: VOQUEZNA® Triple Pak®

Interventions

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.

Helicobacter Pylori Screening and Treatment

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.

Helicobacter Pylori Screening and Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥ 18 years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead
• Phathom Pharmaceuticals: collaborator
• NRG Oncology: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Shria Kumar, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Medicine

Study Record Dates

• First Submitted: October 30, 2025
• First Posted: November 3, 2025
• Study Start: October 15, 2022
• Primary Completion (Estimated): November 6, 2027
• Study Completion (Estimated): November 6, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)