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Free stomach infection test and treatment could prevent cancer in at-risk communities

NCT ID NCT07224035

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study screens 500 adults in South Florida for H. pylori, a stomach infection that can lead to chronic gastritis, ulcers, and gastric cancer. Those who test positive receive free treatment with a three-drug combination (VOQUEZNA® Triple Pak®) for 14 days. The goal is to see if screening and early treatment can prevent serious stomach diseases.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
VOQUEZNA® Triple Pak® (vonoprazan, amoxicillin, clarithromycin) and PYtest® 14C-Urea Breath Test
What this could lead to
If successful, this could show that widespread screening and treatment of H. pylori reduces the risk of stomach cancer and other complications in high-risk communities.
What could go wrong
This is a single-site study with 500 participants, so results may not apply to all populations. The treatment requires a 14-day course of antibiotics, which can cause side effects like diarrhea or allergic reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2022

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of Miami

    Miami, Florida, 33136, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.