NCT07224048

Helicobacter Pylori Screening and Treatment in the At-risk South Florida Community-AIM 2

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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
• Gastric Cancer
• Gastritis H Pylori

Interventions

Type	Name	Description
DRUG	PYTEST® 14C-Urea Capsule Breath Test (at Home)	FDA-approved radiolabeled urea capsule used in the PYtest® 14C-Urea Breath Test for non-invasive detection of Helicobacter pylori. Participants ingest the capsule as part of the at-home retesting protocol. If H. pylori is present, gastric urease hydrolyzes the urea, producing radiolabeled carbon dioxide detectable in the breath sample. The capsule is provided in a self-administered kit assembled by the study team and returned to a TriMed-associated lab for analysis.
DRUG	PYTEST® 14C-Urea Capsule Breath Test (Standard Retesting In-Person)	FDA-approved radiolabeled urea capsule used in the PYtest® 14C-Urea Breath Test for non-invasive detection of Helicobacter pylori. In the standard retesting arm, participants ingest the capsule scheduled in-person. Ten minutes after ingestion, a breath sample is collected by clinical staff using a mylar balloon. The sample is sealed, labeled, and sent to a TriMed-associated laboratory for analysis using a liquid scintillation counter. The test detects the presence of H. pylori by measuring radiolabeled carbon dioxide produced by bacterial urease activity. Results are communicated to participants by the study team, and those who test positive are advised to seek treatment from their primary care provider.

Timeline

• Start date: 2024-11-06
• Primary completion: 2027-11-06
• Completion: 2027-11-06
• First posted: 2025-11-03
• Last updated: 2026-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study