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Helicobacter Pylori Screening and Treatment in the At-risk South Florida Community-AIM 2
Sponsor: University of Miami
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
75
Start Date
2024-11-06
Completion Date
2027-11-06
Last Updated
2026-02-17
Healthy Volunteers
No
Interventions
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.
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.
Locations (1)
University of Miami
Miami, Florida, United States