AuthorisedTherapeutic exploratory (Phase II)Interventional

Faecal Bacteriotherapy for Postantibiotic Diarrhoea in Critically Ill Patients – Randomised Controlled Trial

This study, called a Phase II trial, is investigating a treatment for diarrhoea that can happen after someone has taken antibiotics, particularly if they are critically ill. This type of diarrhoea means your gut can lose its healthy balance of bacteria. The treatment involves using healthy bacteria taken from a donor's poo (this is called a faecal transplant) to help restore that balance. Researchers want to see how well this works and if it helps patients feel better by day 7 after the treatment. They are also carefully watching for any side effects and how long patients stay healthy after leaving the hospital. This research aims to find a new and effective way to help very sick patients recover from this difficult type of diarrhoea.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Fakultni Nemocnice Kralovske Vinohrady

Enrolment target

Start

03 Dec 2024

Postantibiotic diarrhoea in critically ill patients

What is this study about?

When you're very unwell and need strong antibiotics, sometimes these medicines can accidentally upset the good bacteria in your gut. This can lead to a condition called post-antibiotic diarrhoea. If you're already critically ill, this extra problem can make your recovery much harder.

This study is looking into a new treatment called faecal bacteriotherapy, sometimes known as a faecal transplant. It might sound unusual, but it involves carefully prepared healthy gut bacteria from a donor being given to the patient. The idea is to put the good bacteria back into the patient's gut to help it recover and fight off the diarrhoea. Researchers want to understand if this treatment can quickly help critically ill patients get better.

This is a "Phase II" study, which means it's still in the earlier stages. Researchers are focusing on how well the treatment works in the first week and checking for any potential side effects. They are also interested in how long patients stay well after the treatment and if it helps prevent the diarrhoea from coming back before they leave the hospital. This kind of research is vital for finding better ways to care for people who are very sick.

Key takeaways

This study is for critically ill patients with diarrhoea after antibiotics.
It tests a new treatment using healthy gut bacteria (faecal transplant).
The aim is to help patients recover faster and reduce diarrhoea.
Patients will be closely monitored for 7 days and up to 28 days.
It's a Phase II study, looking at how well the treatment works and its safety.

Who may be eligible?

To join this study, people need to be at least 18 years old. Both men and women can take part.

The most important thing about joining this study is that you must be critically ill and have a specific type of diarrhoea that has started after you've taken antibiotics. The doctors running the study will carefully check all your medical information to make sure this study is right for you and that you meet all the necessary health requirements to participate safely.

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 critically ill?
Are you experiencing diarrhoea that started after you took antibiotics?
Are you willing to have medical staff closely monitor your health for a period?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main part of the treatment involves receiving the faecal bacteriotherapy, which is the healthy gut bacteria from a donor. This will happen shortly after you've been chosen for the study.

Over the next 7 days, the medical team will closely monitor your health to see how the treatment is working. This will include keeping an eye on your diarrhoea and checking for any changes in your overall condition. They will also be looking out for any side effects. You will continue to be monitored until you leave the hospital, or for up to 28 days, whichever comes first. During this time, they'll want to see if the diarrhoea stays away.

Potential risks and benefits

Participating in this study might offer some potential benefits, as this new treatment could help to quickly improve your post-antibiotic diarrhoea and potentially aid your recovery when you are critically ill. However, like all medical treatments, there are potential risks, and the researchers will be carefully monitoring for any side effects such as new infections or other serious health issues. The research team will explain all known risks to you. Remember, deciding whether to join a study is always your choice, and you are free to withdraw at any time without explaining why, and your medical care will not be affected.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Czechia

Common questions

What is faecal bacteriotherapy?

It's a treatment where healthy gut bacteria from a donor's poo are given to a patient to help restore the balance of bacteria in their gut.

Why is this treatment being studied?

Researchers want to see if it can effectively treat diarrhoea that critically ill patients get after taking antibiotics and help them recover faster.

Will I know the donor?

No, the faecal donations are from screened, healthy volunteers, and your identity, like theirs, will remain private.

What if I feel worse during the study?

The medical team will be closely monitoring you. If you feel worse or have any concerns, you should tell them immediately. Your safety is their priority.

Who can join this study?

Adults aged 18 or over, who are critically ill and have specific diarrhoea linked to antibiotic use, may be able to join.