H Pylori InfectionPhase 4NCT07224035
Helicobacter Pylori Screening and Treatment in the At-risk South Florida Community- AIM 1
A Phase 4 study testing PYTEST® 14C-Urea Breath Test and VOQUEZNA® Triple Pak® in people with H Pylori Infection and H Pylori Gastritis, 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 olderHealthy volunteers can take part
- Conditions the study is for
- H Pylori Infection, H Pylori Gastritis, Gastric Cancer
- What is being tested?
- PYTEST® 14C-Urea Breath Test and VOQUEZNA® Triple Pak®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2022to 9 Feb 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults ≥ 18 years of age
Who cannot join
- Adults with a personal history of gastric cancer
- Adults with prior history of H. Pylori (HP) treatment and confirmed eradication
- Adults unable to consent
- Adults unable to consent in their preferred language
- Pregnant women, those who are breastfeeding, or those who are planning to become pregnant/breastfeed
- Prisoners
Show all 31Show fewer
- Persons who are allergic, hypersensitive, or unable to take any of the components of the medication regimen VOQUEZNA® Triple Pak®:
- vonoprazan
- amoxicillin or any other beta-lactams (e.g. penicillins and cephalosporins)
- clarithromycin or any other macrolide antimicrobial (e.g. erythromycin)
- Persons presently taking any of the following:
- Rilpivirine-containing products
- Pimozide
- Lomitapide, lovastatin, simvastatin, atorvastatin, and pravastatin
- Ergot alkaloids
- Colchicine (if with kidney or liver impairment)
- Lurasidone
- Drugs known to prolong the QT interval (e.g., pimozide).
- Class IA (e.g., quinidine, procainamide, disopyramide) or Class III (e.g., dofetilide, amiodarone, sotalol) antiarrhythmic agents
- Verapamil, amlodipine, diltiazem, nifedipine
- Nateglinide, pioglitazone, repaglinide, rosiglitazone, and insulin
- Quetiapine
- Warfarin
- Benzodiazepines (e.g. triazolam, midazolam)
- Persons who have any of the following, as they may be prone to adverse effects from the medication regimen:
- History of cholestatic jaundice
- Severe kidney impairment
- Severe hepatic impairment
- Participants with known prolongation of QT interval, ventricular cardiac arrhythmia, including torsades de pointes.
- Participants with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia
- Participants with ongoing mononucleosis
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, H Pylori Gastritis, Gastric Cancer
- Being tested
- PYTEST® 14C-Urea Breath Test, VOQUEZNA® Triple Pak®
- 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 Breath TestDrug
FDA-approved radiolabeled urea capsule used in the PYtest® 14C-Urea Breath Test for non-invasive detection of H. pylori. Participants ingest the capsule, and breath samples are collected and analyzed to determine infection status.
VOQUEZNA® Triple Pak®Drug
FDA-approved combination therapy for H. pylori infection, consisting of:
Vonoprazan tablets 20 mg (1 tablet twice daily for 14 days) Amoxicillin 500 mg (2 tablets twice daily for 14 days) Clarithromycin 500 mg (1 tablet twice daily for 14 days) Medications are dispensed by the study team at the time of diagnosis.
| Study group | Role | What they receive |
|---|---|---|
| Helicobacter Pylori Screening and Treatment | Experimental | Participants in this single-arm study will undergo screening for Helicobacter pylori (H. pylori) using the PYtest® 14C-Urea Capsule Breath Test. This FDA-approved, non-invasive diagnostic method involves swallowing a radiolabeled urea capsule. If gastric urease from H. pylori is present, the urea is hydrolyzed to produce carbon dioxide and ammonia. Ten minutes after ingestion, a breath sample is collected in a balloon and transferred into a collection fluid to trap the labeled carbon dioxide. The sample is analyzed using a liquid scintillation counter to determine infection status.
Participants who test positive will receive VOQUEZNA® Triple Pak® therapy, dispensed by the study team at the time of diagnosis. Phathom Pharmaceuticals will supply the medications (which include complete medication package insert), but the study team hold and dispenses medications. Receives: Drug: PYTEST® 14C-Urea Breath Test; Drug: VOQUEZNA® Triple Pak® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of participants diagnosed with Helicobacter pylori using PYTEST® breath test at baseline
This measure determines the percent of participants who test positive for Helicobacter pylori at baseline. This is done using the PYTEST® 14C-Urea Breath Test. Participants will receive a diagnosis on-site, approximately 30 minutes after administration of urea capsule. This will allow immediate treatment free of charge (VOQUEZNA® Triple Pak®) initiation for positive eligible participants.
Measured: Baseline
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 start15 Oct 2022
- Primary completion9 Feb 2026
- Study completion9 Feb 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 430 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
- David Goldberg, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07224035
- Sponsor's protocol ID
- 20211207-AIM 1
- 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 1
- ClinicalTrials.gov ID
- NCT07224035
- Acronym / sponsor ID
- 20211207-AIM 1
- Conditions
- H Pylori Infection, H Pylori Gastritis, Gastric Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Phathom Pharmaceuticals, NRG Oncology
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 9 Feb 2026 (actual)
- Study completion
- 9 Feb 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Helicobacter Pylori Screening and Treatment | Experimental | Drug: PYTEST® 14C-Urea Breath Test, Drug: VOQUEZNA® Triple Pak®Participants in this single-arm study will undergo screening for Helicobacter pylori (H. pylori) using the PYtest® 14C-Urea Capsule Breath Test. This FDA-approved, non-invasive diagnostic method involves swallowing a radiolabeled urea capsule. If gastric urease from H. pylori is present, the urea is hydrolyzed to produce carbon dioxide and ammonia. Ten minutes after ingestion, a breath sample is collected in a balloon and transferred into a collection fluid to trap the labeled carbon dioxide. The sample is analyzed using a liquid scintillation counter to determine infection status. Participants who test positive will receive VOQUEZNA® Triple Pak® therapy, dispensed by the study team at the time of diagnosis. Phathom Pharmaceuticals will supply the medications (which include complete medication package insert), but the study team hold and dispenses medications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults ≥ 18 years of age
Key exclusion criteria (31 listed)
- Adults with a personal history of gastric cancer
- Adults with prior history of H. Pylori (HP) treatment and confirmed eradication
- Adults unable to consent
- Adults unable to consent in their preferred language
- 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 Breath TestFDA-approved radiolabeled urea capsule used in the PYtest® 14C-Urea Breath Test for non-invasive detection of H. pylori. Participants ingest the capsule, and breath samples are collected and analyzed to determine infection status. | Drug | Helicobacter Pylori Screening and Treatment |
| VOQUEZNA® Triple Pak®FDA-approved combination therapy for H. pylori infection, consisting of: Vonoprazan tablets 20 mg (1 tablet twice daily for 14 days) Amoxicillin 500 mg (2 tablets twice daily for 14 days) Clarithromycin 500 mg (1 tablet twice daily for 14 days) Medications are dispensed by the study team at the time of diagnosis. | Drug | Helicobacter Pylori Screening and Treatment |
Primary outcome
Percent of participants diagnosed with Helicobacter pylori using PYTEST® breath test at baseline
Time frame: Baseline
This measure determines the percent of participants who test positive for Helicobacter pylori at baseline. This is done using the PYTEST® 14C-Urea Breath Test. Participants will receive a diagnosis on-site, approximately 30 minutes after administration of urea capsule. This will allow immediate treatment free of charge (VOQUEZNA® Triple Pak®) initiation for positive eligible participants.
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.
David Goldberg, 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 Breath Test and VOQUEZNA® Triple Pak® in people with H Pylori Infection and H Pylori Gastritis, 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 1 inclusion and 31 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?
Percent of participants diagnosed with Helicobacter pylori using PYTEST® breath test at baseline (time frame: Baseline). 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.