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

University of Miami

Status and phase: Enrolling; Phase 4

Conditions: Gastric Cancer; Gastritis H Pylori; H. Pylori Infection

Treatments: Drug: PYTEST® 14C-Urea Capsule Breath Test (Standard Retesting In-Person); Drug: PYTEST® 14C-Urea Capsule Breath Test (at Home)

Study type: Interventional

Funder types: Other

Identifiers

NCT07224048

20211207-AIM 2

Details and patient eligibility

About

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 2 patient groups

At-Home Retesting Strategy

Experimental group

Description:

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.

Treatment:

Drug: PYTEST® 14C-Urea Capsule Breath Test (at Home)

Standard Care Retesting Strategy

Active Comparator group

Description:

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.

Treatment:

Drug: PYTEST® 14C-Urea Capsule Breath Test (Standard Retesting In-Person)