Active — Not RecruitingPhase 4

Helicobacter Pylori Screening and Treatment in the At-risk South Florida Community- AIM 1

United States500 participantsStarted 2022-10-15

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults ≥ 18 years of age Exclusion Criteria: * 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 * 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 h…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percent of participants diagnosed with Helicobacter pylori using PYTEST® breath test at baseline

Timeframe: Baseline

Trial details

NCT IDNCT07224035

SponsorUniversity of Miami

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-11-06

View on ClinicalTrials.gov More H Pylori Infection trials