Nasal application of Staphylococcus lugdunensis for decolonization of Staphylococcus aureus – a first-in-human proof-of-concept microbiome intervention study
Many healthy people carry a common germ called Staphylococcus aureus inside their nose without feeling sick. However, it can sometimes cause skin problems or more serious infections, especially if it gets into cuts or during hospital stays. Doctors usually use antibiotic creams to clear it, but germs can become resistant to these medicines. This early clinical trial is testing a new, natural approach. Scientists are applying a different, harmless bacterium called Staphylococcus lugdunensis inside the nostrils. This 'friendly' bacteria naturally fights off Staphylococcus aureus. Because this is a Phase 1 study, the main goal is to test safety in humans for the very first time. Researchers want to find out if the treatment is well-tolerated, causes any side effects, and successfully clears the unwanted bacteria from the nose.
At a glance
What is this study about?
Many of us carry bacteria in our noses without ever knowing it. One very common germ is called Staphylococcus aureus, or 'Staph' for short. For most people, it lives quietly without causing harm. However, if it enters a break in the skin or if a person has a weak immune system, it can lead to troublesome skin sores or even severe infections. To prevent this, doctors often try to clear the germ using antibiotic nasal ointments. Unfortunately, overusing antibiotics can make bacteria tough and resistant to regular medicines.
To solve this problem, scientists are looking at the 'microbiome'—the community of harmless bacteria that naturally live on and inside our bodies. Researchers discovered that another natural bacterium, known as Staphylococcus lugdunensis, produces its own natural shield that stops harmful Staph from growing. In this clinical trial, doctors are testing whether putting this helpful bacteria into the nose can gently push out the unwanted Staph bacteria.
This is a 'first-in-human' study, which means it is the very first time this specific treatment is being given to people. The main purpose is not yet to prove it works as a cure, but to make sure it is completely safe and comfortable. If successful, this type of gentle treatment could offer a brand-new way to protect people from infections without relying on standard antibiotics.
Key takeaways
- Tests a friendly bacterium to clear Staphylococcus aureus from the nose.
- First-in-human trial focusing primarily on safety and comfort.
- Open to adults aged 18 and older who carry the bacteria in their nose.
- Aims to find new ways to prevent infections without using traditional antibiotics.
- Participation involves gentle nasal swabs and regular clinic check-ups.
Who may be eligible?
This study is open to adults aged 18 and over who naturally carry Staphylococcus aureus in their nose, either all the time or on and off. You do not need to be unwell to take part; in fact, volunteers are usually otherwise healthy carriers of the germ.
Doctors will test your nose using a quick swab to see if the bacteria are present before you can join. If you do not carry this specific bacteria, or if you have certain active nasal infections or skin conditions inside the nose, this trial might not be suitable for you.
Because this is an early safety trial, people with weakened immune systems or those taking strong medications that fight bacteria might be asked to wait. The study team will review your full medical history to make sure taking part is safe for you.
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.
- I am aged 18 or older.
- I am willing to have a simple swab taken from inside my nose.
- I have been told, or suspect, that I carry Staph bacteria in my nose.
- I am able to travel to the clinic for several check-up visits.
- I am not currently taking strong antibiotics that might interfere with the trial.
What does participation involve?
Taking part begins with a screening appointment where the research team will swab the inside of your nose to check for the bacteria and review your general health. If you are eligible, you will be given the study treatment, which involves applying a small amount of liquid or cream containing the friendly bacteria directly into your nostrils.
You will need to attend several follow-up visits at the study clinic over a set period of weeks. During these visits, doctors will check your nose for any redness or irritation, ask how you are feeling, and take gentle swabs to see if the bacteria levels have changed. The team will provide a clear calendar of all visits before you agree to join.
Potential risks and benefits
Locations (1)
- —UnverifiedGermany
Common questions
What does 'first-in-human' mean?
It means this specific treatment has been tested in laboratories before, but this trial is the very first time it is being given to people to test its safety.
Is Staphylococcus aureus dangerous?
For most healthy people, it lives harmlessly on the skin or in the nose. However, it can cause infections if it enters a wound or if someone is unwell.
Will having bacteria put in my nose hurt?
No, applying the treatment should feel like using a normal nasal drop or gentle ointment, though it might cause mild tickling or a runny nose.
Can I leave the study if I change my mind?
Yes, taking part is completely voluntary. You can stop participating at any time, for any reason, without giving an explanation.
Will I be paid for taking part?
Many clinical trials offer travel expenses or compensation for your time. The research team will explain the exact details before you sign up.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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