RecruitingOBSERVATIONAL

The Gut Microbiome - Source of Sepsis and Novel Target in Intensive Care Units?

This research explores a potential link between the germs in our gut and severe illnesses like sepsis, especially in patients in intensive care units (ICUs). Scientists are studying how powerful antibiotics, often needed for serious infections, might change the balance of these gut germs. They want to see if these changes are connected to brain issues, like confusion or longer-term memory problems, that can happen after critical illness. The study aims to understand how the body's natural defences (immune system) are affected by gut germ changes and hopes to find new ways to help patients recover better, both physically and mentally, following a stay in critical care.

At a glance

Status

Recruiting

Sponsor

Jena University Hospital

Enrolment target

100

Start

27 Dec 2024

Estimated completion

31 Dec 2026

Critical Illness Intensive Care Unit Delirium Neurocognitive Deficit Microbiome,immune Function, Critically Ill Infection in ICU Sepsis

What is this study about?

When you're very unwell and in intensive care, doctors often need to give you strong antibiotics to fight serious infections. While these medicines are vital, they can also affect the trillions of tiny germs that live in your gut. These 'gut microbes' play a big role in your overall health, including how your immune system works and even how your brain functions. This study is trying to understand if changes to these important gut germs, caused by illness or antibiotics, might be linked to problems like delirium (confusion) during intensive care, and longer-term thinking or memory issues after leaving hospital.

The researchers will be looking closely at people who are critically ill, some of whom are receiving powerful antibiotics. They'll also involve people who have recovered from sepsis, a life-threatening infection, but may still be experiencing long-term effects. By comparing these groups, the team hopes to figure out which specific changes in gut germs might be the most important. They're also keen to see how these changes affect the body's natural defences and whether they can influence how the brain recovers after a severe illness.

The main goal is to discover new ways to support patients in intensive care. If we can better understand the connection between gut germs and recovery, it might open doors to new treatments or approaches that could help prevent infections and reduce long-term brain problems, leading to a better quality of life for patients after a critical illness.

Key takeaways

Looks at how gut germs affect recovery from critical illness.
Investigates the link between antibiotics, gut changes, and brain function.
Aims to improve care for patients in intensive care units.
Involves collecting samples and checking thinking skills over 6 months.
Participation will not change your current medical treatment.

Who may be eligible?

This study is looking for volunteers who are 18 years old or older. You might be able to take part if you are currently very ill and in intensive care, particularly if you are receiving specific strong antibiotics (like meropenem or piperacillin/tazobactam) or are expected to stay in intensive care for more than three days. The study also includes people who have previously had sepsis and have now recovered, but who are part of an existing group of sepsis survivors.

However, there are reasons why you might not be able to join. For example, if you have certain gut conditions like inflammatory bowel disease, or have recently had major bowel surgery. You also can't be in the study if you've recently had chemotherapy, or if you're taking specific oral antibiotics (oral vancomycin). If you have certain ongoing brain conditions like active dementia, schizophrenia, or a recent stroke, you wouldn't be eligible.

Finally, if you have certain medical devices in your body (like some pacemakers or implants) or have severe claustrophobia, you wouldn't be able to have the MRI scans that are part of the study. The medical team will check all these details carefully to make sure the study is right and 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.

Are you 18 years old or older?
Are you currently very ill in intensive care or have you recovered from sepsis?
Do you have inflammatory bowel disease or have you recently had major bowel surgery?
Do you have certain metal implants or severe claustrophobia that would prevent an MRI scan?
Have you had chemotherapy in the last six months or have certain serious brain conditions?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be asked to provide some samples, including stool (poo) samples, from your rectum, and blood samples. These samples will be collected at five different times: three times while you are in the intensive care unit (on the first day, day 7, and day 14 of the study), and then two more times after you have left the hospital, at 3 months and 6 months later.

To check your brain function, nurses will do daily short screening tests during your ICU stay to look for confusion (delirium). When you are ready to leave the hospital, you will have a couple of tests to check your memory and thinking skills. For the follow-up visits at 3 and 6 months, you may have special brain scans called functional MRI, along with more detailed memory and thinking tests. There is no new medication involved in this study; it is focused on understanding how your body responds to your illness and current treatments. The total duration of your participation would be about 6 months from when you join.

Potential risks and benefits

Taking part in this study may not directly benefit you, but the information collected could help doctors better understand how to treat future patients with severe illnesses. The main risks involve the blood tests, which may cause minor bruising or discomfort. MRI scans are generally very safe but require you to lie still in an enclosed space, which some people find uncomfortable, and they can't be done if you have certain metal implants. You are always free to change your mind and withdraw from the study at any time without it affecting your medical care.

Locations (1)

Klinik für Anästhesiologie und Intensivmedizin, Universitätsklinikum Jena
Verified postcode
Jena, Germany· Recruiting

Common questions

What is 'gut microbiome'?

It's the name for all the tiny germs, like bacteria, that live in your intestines. They play a very important role in your health.

What is 'sepsis'?

Sepsis is a life-threatening reaction to an infection. It happens when your immune system overreacts to an infection and starts to damage your own tissues and organs.

Why are antibiotics mentioned?

Strong antibiotics are often needed for serious infections, but they can also change the balance of the helpful germs in your gut. Researchers want to see how these changes affect recovery.

What does 'brain dysfunction' mean?

It refers to problems with thinking, memory, or attention that can sometimes happen after being very ill, especially in intensive care. This includes things like delirium or difficulties concentrating.

Will taking part change my medical treatment?

No, this study is observational, which means it won't change your medical treatment. It's about collecting information to understand your illness and recovery better.

How to find out more

Johannes Ehler, Priv.-Doz. Dr. med.

johannes.ehler@med.uni-jena.de +49 36419323397 Official trial record

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