H. Pylori InfectionPhase 4NCT07224048
Helicobacter Pylori Screening and Treatment in the At-risk South Florida Community-AIM 2
A Phase 4 study testing PYTEST® 14C-Urea Capsule Breath Test (at Home) and PYTEST® 14C-Urea Capsule Breath Test (Standard Retesting In-Person) in people with H. Pylori Infection and Gastric Cancer, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- H. Pylori Infection, Gastric Cancer, Gastritis H Pylori
- What is being tested?
- PYTEST® 14C-Urea Capsule Breath Test (at Home) and PYTEST® 14C-Urea Capsule Breath Test (Standard Retesting In-Person)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2024to 14 Apr 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant women, those who are breastfeeding, or those who are planning to become pregnant/breastfeed
Trial locations and contacts
1 site in 1 country.
About this study
- 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
- Being tested
- PYTEST® 14C-Urea Capsule Breath Test (at Home), PYTEST® 14C-Urea Capsule Breath Test (Standard Retesting In-Person)
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PYTEST® 14C-Urea Capsule Breath Test (at Home)Drug
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)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| At-Home Retesting Strategy | Experimental | 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. Receives: Drug: PYTEST® 14C-Urea Capsule Breath Test (at Home) |
| Standard Care Retesting Strategy | Active comparator | 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. Receives: Drug: PYTEST® 14C-Urea Capsule Breath Test (Standard Retesting In-Person) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard vs At-Home Retesting for eradication
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.
Measured: 6 weeks after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2025
- Study start6 Nov 2024
- Primary completion14 Apr 2026
- Study completion14 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for H. Pylori InfectionStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Phathom Pharmaceuticals, NRG Oncology
- Responsible party
- Principal investigator, David Goldberg, University of Miami
- Investigators
- Shria Kumar, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07224048
- Sponsor's protocol ID
- 20211207-AIM 2
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helicobacter Pylori Screening and Treatment in the At-risk South Florida Community-AIM 2
- ClinicalTrials.gov ID
- NCT07224048
- Acronym / sponsor ID
- 20211207-AIM 2
- Conditions
- H. Pylori Infection, Gastric Cancer, Gastritis H Pylori
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Phathom Pharmaceuticals, NRG Oncology
- Study start
- 6 Nov 2024 (actual)
- Primary completion
- 14 Apr 2026 (actual)
- Study completion
- 14 Apr 2026 (actual)
- First posted
- 3 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| At-Home Retesting Strategy | Experimental | Drug: 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 | Active comparator | Drug: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Pregnant women, those who are breastfeeding, or those who are planning to become pregnant/breastfeed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | At-Home Retesting Strategy |
| 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. | Drug | Standard Care Retesting Strategy |
Primary outcome
Standard vs At-Home Retesting for eradication
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shria Kumar, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PYTEST® 14C-Urea Capsule Breath Test (at Home) and PYTEST® 14C-Urea Capsule Breath Test (Standard Retesting In-Person) in people with H. Pylori Infection and Gastric Cancer, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standard vs At-Home Retesting for eradication (time frame: 6 weeks after completion of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.