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At-Home breath test could help prevent stomach cancer

NCT ID NCT07224048

Prevention Sponsor: University of Miami Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study screens people in South Florida for H. pylori, a stomach infection that can lead to chronic gastritis, ulcers, and even stomach cancer. Those who test positive receive treatment, and the study compares at-home breath testing versus in-person retesting to confirm the infection is gone. The goal is to make screening easier and 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
PYTEST® 14C-Urea Capsule Breath Test (at-home and in-person)
What this could lead to
If successful, this could show that at-home testing is as effective as in-person retesting for confirming H. pylori eradication, making screening more accessible and helping prevent stomach cancer.
What could go wrong
This is a small, single-site study (75 participants) focused on testing methods, not a large-scale prevention trial. The at-home test may be less accurate or harder to complete than in-person testing.

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 75 people

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

Started

Nov 2024

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

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * 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 Exclusion Criteria: * Pregnant women, those who are breastfeeding, or those who are planning to become pregnant/breastfeed

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Conditions

The condition(s) this trial relates to.

gastric neoplasm Helicobacter pylori infectious disease gastric cancer prevention target gastritis prevention target peptic ulcer disease prevention target

As listed by the trial registrant

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

Gastric cancer Gastritis H pylori H.pylori infection

Contacts and locations

Locations

  • University of Miami

    Miami, Florida, 33136, United States

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