RecruitingOBSERVATIONAL

Helicobacter Pylori Local Prevalence and Antibiotic Resistance

This study, called "HelicoPTER", is looking into a common tummy bug called Helicobacter pylori (H. pylori) in Germany. The main goals are to find out how many people have this infection and if the usual medicines (antibiotics) are still effective against it, as antibiotic resistance is a growing problem. By understanding this better, doctors can choose the right treatments and improve how they detect and manage H. pylori. The study also hopes to find better ways to spot people at higher risk of developing serious stomach problems, like stomach cancer, due to the infection, which could lead to earlier and more effective prevention strategies.

At a glance

Status

Recruiting

Sponsor

Technical University of Munich

Enrolment target

20,000

Start

31 Mar 2021

Estimated completion

31 Dec 2035

Helicobacter Pylori Infection Helicobacter Pylori Gastritis Drug Resistant Bacterial Infection Antibiotic Resistant Infection Gastric Cancer Microbial Colonization

What is this study about?

This research study is all about a common type of germ called Helicobacter pylori, or H. pylori for short. This germ can live in your stomach and, for some people, can lead to issues like stomach inflammation (gastritis), ulcers, and in rare cases, even stomach cancer. The study wants to understand two main things: firstly, how common this H. pylori infection is in different parts of Germany. This helps doctors know how likely someone is to have the infection.

Secondly, and very importantly, the study wants to find out if the medicines normally used to treat H. pylori (antibiotics) are still working well. Over time, germs can become resistant to medicines, meaning the treatments stop being effective. Knowing which medicines work and which don't is crucial for doctors to choose the best treatment for you. The researchers are also exploring new, faster ways to check for this resistance.

Finally, the study hopes to spot warning signs in people with H. pylori that might show they are at a higher risk of developing more serious conditions, like stomach cancer, earlier on. This could help doctors decide if someone needs treatment sooner to prevent these problems from developing. By gathering all this information, the study aims to improve how H. pylori infections are diagnosed and treated, ultimately benefiting patients.

Key takeaways

The study helps understand how common H. pylori is.
It checks if current antibiotic treatments are still working.
Aims to find better ways to spot people at risk of stomach problems.
No new medicines are given as part of the study.
Participation will help improve H. pylori care for everyone.
You can stop participating at any time.

Who may be eligible?

To be able to take part in this study, you need to be at least 18 years old. It's really important that you can understand what the study involves and are able to give your full permission to participate.

This means you need to be able to understand the study information and agree to take part in two separate parts: the main HelicoPTER study and also allow your samples to be stored in something called the HEPY biobank for future research.

If you are unable to understand the study or give your consent, you wouldn't be able to join this particular research.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Can you fully understand what the study involves?
Are you able to agree to take part in the main study?
Are you able to agree to have your samples stored for future research?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the first step involves a blood test to see if you have signs of an H. pylori infection. If this blood test suggests you might have it, you'll then have a special breath test to confirm the infection. If both tests show you have H. pylori, you might be invited to be part of a second stage of the study.

In this second stage, if you need to have a stomach examination (called an endoscopy) for medical reasons, doctors would take small tissue samples (biopsies) during this procedure. These samples, along with blood and stool samples, would be used to check which antibiotics would work best against the H. pylori and also to look closer at the germs and your body's response. The total duration of your involvement could vary depending on whether you move to the second stage and for how long observations are needed.

Potential risks and benefits

Taking part in this study won't offer a direct benefit to you personally, but the information gathered will be very valuable in improving how H. pylori infections are diagnosed and treated for everyone in the future. The risks involved are generally low, mainly related to blood tests and the breath test, which are routine procedures. If you proceed to the second stage and have an endoscopy, the risks are those normally associated with that procedure. You are completely free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Department of Medicine II, University Hospital of Munich
Verified postcode
Munich, Germany· Recruiting

Common questions

What is H. pylori?

H. pylori is a common type of bacteria (germ) that can live in your stomach and sometimes cause problems like indigestion, ulcers, or inflammation.

Why is this study important for me?

While it might not directly benefit you, the study helps doctors understand H. pylori better. This means they can make better choices about how to test for and treat the infection for patients in the future.

Will I have to take any new medicine?

No, this study is about observation and testing. You won't be given any new medicines as part of this research, though your doctor might prescribe treatment if you have H. pylori.

What is antibiotic resistance?

Antibiotic resistance means that some germs, like H. pylori, have learned to fight off the medicines designed to kill them, making treatments less effective.

Can I leave the study if I change my mind?

Yes, absolutely. You can choose to stop taking part in the study at any time, and you don't need to give a reason. Your medical care will not be affected.

How to find out more

Markus Gerhard, Prof.

markus.gerhard@tum.de +49894140 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.