RecruitingOBSERVATIONAL

Clostridioides Difficile Infection: Analyzing CLInic Evolution and Bacterial Clearance

This study focuses on a gut infection called Clostridioides difficile, often known as C. diff. C. diff can cause severe diarrhoea and, for some people, it keeps coming back even after treatment. This is a big problem because it affects patients' quality of life and is expensive to manage. The research aims to follow patients with C. diff in hospital to see how their infection develops and how their body clears the bacteria. We'll be looking closely at their gut health and immune system. By understanding why the infection comes back in some people and not others, we hope to find better ways to prevent and treat it in the future, improving care for patients.

At a glance

Status

Recruiting

Sponsor

Fondation Hôpital Saint-Joseph

Enrolment target

100

Start

18 Sep 2023

Estimated completion

17 Jan 2027

Clostridium Difficile Infections

What is this study about?

Imagine your gut has a garden of helpful bacteria keeping things healthy. Sometimes, especially after taking antibiotics, this garden can get disrupted, allowing a troublesome weed called Clostridioides difficile (C. diff) to grow. This germ can cause tummy troubles, from watery diarrhoea to more serious problems.

C. diff can be tricky because even after treatment, it sometimes comes back. This is called a recurrence, and it can be very upsetting and difficult for patients. Current treatments mostly involve special antibiotics, but they don't always stop the infection from returning. Also, some of the most effective treatments can be quite expensive, limiting who can get them.

This study wants to understand C. diff better. We'll be carefully observing patients with the infection to see how their body reacts to it and how it eventually clears the bacteria. We're especially interested in how their gut `garden` (called the microbiota) and their immune system fight off the infection. By gathering this information, we hope to discover what makes some people clear the infection easily, while others suffer from it coming back. This knowledge could lead to new and better ways to prevent C. diff recurrences, making a real difference to people's health and well-being.

Key takeaways

This study explores a common gut infection called C. diff.
It aims to understand why C. diff often comes back after treatment.
Researchers will study patients' gut health and immune responses.
The goal is to find better ways to prevent and treat C. diff in the future.
Participation will not change your standard medical care.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old and currently in hospital at GH Paris Saint-Joseph. You must have been diagnosed with a C. diff infection, or had it come back, and be receiving treatment for it. You should also be able to speak French and agree to take part.

There are certain situations where you wouldn't be able to join. For example, if you are under court protection or cannot make your own medical decisions. If you are pregnant or breastfeeding, you also won't be able to participate. The study is open to both men and women.

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 a patient at GH Paris Saint-Joseph with a C. diff infection?
Are you able to speak and understand French?
Are you free to make your own medical decisions (not under guardianship or legal protection)?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

This study involves following your health journey if you have a C. diff infection. You will continue to receive your standard C. diff treatment as prescribed by your doctor. The researchers will then collect information about your infection, how it develops, and how your body fights it off. This will involve regular checks while you are in hospital and potentially some follow-up after you leave. They may collect samples, such as stool samples, to understand your gut bacteria and immune response. The total duration of your involvement will depend on how long your infection lasts and your follow-up needs.

Potential risks and benefits

Taking part could help us learn valuable information about C. diff which may lead to better treatments for future patients. You will continue to receive the best care for your C. diff infection as part of the study. All medical procedures carry some level of risk; however, participation in this study mainly involves observation and collection of information, with minimal additional procedures beyond your usual hospital care. You are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

Fondation Hôpital Saint-Joseph
Verified postcode
Paris, France· Recruiting

Common questions

What is C. diff?

C. diff is a type of germ that can cause stomach upset and severe diarrhoea, especially after taking antibiotics.

Why is this study important?

It aims to understand why C. diff infections sometimes come back so we can find better ways to prevent and treat them.

Will I get different treatment if I join?

No, you will receive the standard treatment your doctor recommends for your C. diff infection.

What will I have to do if I take part?

You'll be observed during your hospital stay, and researchers might collect samples, like stool, as part of your care.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time without it affecting your medical care.

How to find out more

Assaf MIZRAHI, MD

amizrahi@ghpsj.fr 144127030 Official trial record

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