AuthorisedTherapeutic confirmatory (Phase III)Interventional

A Randomized, Multicenter, Single-Blind, Parallel-Group Phase III Non-Inferiority Trial Comparing the Efficacy and Tolerability of a Fixed-Dose Combination of Metronidazole, Bismuth Oxide and Tetracycline HCl to Standard Concomitant Non-Bismuth Quadruple Therapy for First-Line Eradication of Helicobacter pylori in Adults.

This study is looking at adults with a common stomach infection called *Helicobacter pylori*. We are comparing a new combination medicine, which includes several drugs in one, to the usual treatment. The main goal is to see if this new medicine is just as good as the standard treatment at getting rid of the infection. We also want to understand if it's easier to tolerate, meaning if patients have fewer side effects or can stick to the treatment better. By finding effective and tolerable treatments, we hope to improve how we manage *H. pylori* infections, which can sometimes lead to stomach ulcers or other issues.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Verisfield Single Member S.A.

Enrolment target

420

Start

28 May 2026

Helicobacter Pylori Infection

What is this study about?

This study is focused on improving the treatment for a common stomach infection called *Helicobacter pylori*, often shortened to *H. pylori*. This bacteria can live in your stomach and sometimes cause problems like ulcers or indigestion. Getting rid of *H. pylori* is important for your stomach health.

Researchers are comparing two different ways to treat this infection. One is a new combination of medicines that come together in a single dose. The other is the standard treatment that doctors usually prescribe. The main aim is to find out if this new combination medicine works just as well as the standard treatment in clearing up the infection. They are also looking at how well people can take the medicines and if there are any side effects.

This is a 'Phase III' study, which means it's a very important step where a new treatment is compared to existing ones in a larger group of people. If the new combination medicine is found to be as effective and potentially easier to take, it could offer a new option for people with *H. pylori* infection. The success of the treatment will be checked using a simple breath test after the medicines have been taken.

Key takeaways

Tests a new combination medicine against standard treatment for *H. pylori* infection.
Main goal is to see if the new medicine works just as well.
Also looking at side effects and how easy the medicine is to take.
A simple breath test will confirm if the infection is gone.
For adults with a first-time *H. pylori* diagnosis.
You won't know which treatment you receive.

Who may be eligible?

This study is looking for adults who have been diagnosed with an *Helicobacter pylori* infection for the first time. You must be at least 18 years old to take part. The study needs both men and women to participate.

There might be other health conditions or medications that would prevent someone from joining, which the study doctors would check carefully. For example, if you've already tried to treat *H. pylori* before, this study might not be for you.

It's important to discuss your full medical history with the study team to see if this trial is a good fit for you.

Quick self-check

I am 18 years old or older.
I have been diagnosed with *Helicobacter pylori* infection.
This is the first time I am being treated for *H. pylori*.
I am able to take medications as prescribed.

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you'll be given either the new combination medicine or the standard treatment. You won't know which one you're getting, but the study team will know. You'll need to take the medicines as instructed for a certain period. During this time, you'll likely keep a diary to record how you're feeling and any medicines you take. You will have a breath test after you finish the medicine to see if the infection is gone. There will also be check-ups to monitor your progress and make sure you're doing okay with the treatment. The total time you'd be involved in the study would include the treatment period and follow-up checks.

Potential risks and benefits

Taking part in a study like this could potentially offer you access to a new treatment option for *H. pylori* that isn't widely available yet. There's also the benefit of close medical supervision throughout the study. However, like all medicines, there's a chance you might experience side effects from either the new combination medicine or the standard treatment. These would be explained to you in detail. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Greece

Common questions

What is *Helicobacter pylori*?

*Helicobacter pylori* is a common type of bacteria that can live in your stomach and sometimes cause problems like stomach ulcers or indigestion.

How will you know if the treatment works?

After you finish taking the medicine, you will have a simple breath test. If the test shows the bacteria are gone, the treatment is considered successful.

Will I know which treatment I'm getting?

No, you won't know if you're getting the new combination medicine or the standard treatment. This helps make the study results fair and accurate.

What if I experience side effects?

The study team will monitor you closely for any side effects. You should always tell them about any new or unusual feelings you have during the study.

How long will I need to be in the study?

The study involves a period of taking medicine and then follow-up checks, which the study team will explain in detail before you start.