Gastric Cancer, Gastritis H Pylori, H. Pylori Infection
Conditions
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.
Interventions
DRUGPYTEST® 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.
DRUGPYTEST® 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.
Sponsors
University of Miami
Phathom Pharmaceuticals
NRG Oncology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORShria Kumar, MD
University of Miami
Outcome results
None listed