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

Not Applicable

Recruiting

• Conditions: H. Pylori Infection; Gastric Cancer; Gastritis H Pylori
• Interventions: Drug: PYTEST® 14C-Urea Capsule Breath Test (at Home); Drug: PYTEST® 14C-Urea Capsule Breath Test (Standard Retesting In-Person)

• Registration Number: NCT07224048
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-06
• Study First Submitted: 2025-10-30
• Study First Submitted QC: 2025-10-30
• Status Verified: 2025-11
• Study First Posted: 2025-11-03
• Last Update Submitted: 2025-11-03
• Last Update Posted: 2025-11-04
• Primary Completion: 2027-11-06
• Study Completion: 2027-11-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Participants in Aim 1 that received a positive result for H. Pylori (HP) testing
• Participants are advised to only begin re-testing procedures in Aim 2 if they have finished the medication regimen for HP treatment at least 6 weeks ago

Exclusion Criteria

• Pregnant women, those who are breastfeeding, or those who are planning to become pregnant/breastfeed

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
At-Home Retesting Strategy	PYTEST® 14C-Urea Capsule Breath Test (at Home)	Participants who test positive for H. pylori (HP), will receive a kit that contains a PYtest® 14C-Urea Breath Test (TriMed). Participants will complete the retest at-home at least 6 weeks after treatment. Study team will contact the participant to inquire about retesting and the post treatment survey. The kit will include an envelope, materials for the test, and a return form. PYtest® is a quantitative and non-invasive method for the diagnosis of HP. The test is conducted with the swallowing of a urea capsule. If gastric urease from HP is present, the urea is split to form carbon dioxide and ammonia. Ten minutes after the capsule is ingested, a breath sample is collected in a balloon. The balloon is tied and mailed along with the return form to be analyzed by an outside laboratory. The study team will call the participant to provide results. Those who retest positive will be instructed to seek treatment from their primary care provider.
Standard Care Retesting Strategy	PYTEST® 14C-Urea Capsule Breath Test (Standard Retesting In-Person)	Participants who test positive for H. pylori (HP), will complete their retest in-person with the study team. Study team will contact the participant to inquire about scheduling the retest and the post treatment survey. Retest will be completed in Don Soffer or at one of study's community sites. PYtest® is a urea breath test and is a quantitative and non-invasive method for the diagnosis of HP. The test is conducted with the participant swallowing a urea capsule. If gastric urease from HP is present, the urea is split to form carbon dioxide and ammonia. Ten minutes after the capsule is ingested by the participant, a breath sample is collected in a balloon. This liquid is analyzed on site by the liquid scintillation counter, by the study team. Those who test positive will be instructed to seek treatment for H. pylori infection.

Primary Outcome Measures

Name	Time	Method
Standard vs At-Home Retesting for eradication	6 weeks after completion of treatment	Percent of participants who complete at-home retesting, compared to the percent of participants who complete standard retesting, with successful eradication defined as obtaining a negative test result upon retesting.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States