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

NCT07224035 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2026-02-17

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Phathom Pharmaceuticals

    collaborator UNKNOWN

  • NRG Oncology

    collaborator OTHER

  • University of Miami

    lead OTHER

Principal Investigators

  • Shria Kumar, MD · University of Miami

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-15
Primary Completion
2027-11-06
Completion
2027-11-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07224035 on ClinicalTrials.gov