NCT07224035CompletedPhase 4
Helicobacter Pylori Screening and Treatment in the At-risk South Florida Community- AIM 1
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 430 (actual)
- First submitted
- 30 Oct 2025
- Start date
- 15 Oct 2022
- Primary completion date
- 9 Feb 2026
- Lead sponsor
- University of Miami
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07224035
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 430
- From 15 Oct 2022 to the primary completion date, 9 Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Adults with prior history of H. Pylori (HP) treatment and confirmed eradication
- Persons who have any of the following, as they may be prone to adverse effects from the medication regimen:
Other illness
- Adults with a personal history of gastric cancer
- Persons who are allergic, hypersensitive, or unable to take any of the components of the medication regimen VOQUEZNA® Triple Pak®:
- Colchicine (if with kidney or liver impairment)
- History of cholestatic jaundice
- Severe kidney impairment
- Severe hepatic impairment
- Participants with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia
Lab values
- Drugs known to prolong the QT interval (e.g., pimozide).
- Participants with known prolongation of QT interval, ventricular cardiac arrhythmia, including torsades de pointes.
Other
- 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
- 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
- Lurasidone
- 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)
- Participants with ongoing mononucleosis
Who the study is looking for
- Adults ≥ 18 years of age
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Miami Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.