Randomized, double-blind and multicentric study to assess the efficiency, security and tolerability of the faecal microbiota transfer in capsule form vs. placebo for the treatment of patients with non-alcoholic steatohepatitis (EMOTION)
This research study, called EMOTION, is investigating a new way to treat non-alcoholic steatohepatitis (NASH), a type of liver disease. Researchers are testing a capsule containing healthy gut bacteria against a placebo (a dummy pill) to see if it can improve the liver condition without causing the scarring to get worse. This is a "Phase II" study, which means it helps us learn more about how well the treatment works and if it's safe. They will be carefully checking participants' liver health, looking for side effects, and monitoring overall well-being over 72 weeks (about a year and a half). The goal is to find out if this new approach could be a useful future treatment option for NASH.
At a glance
What is this study about?
This study, called EMOTION, is looking into a new treatment for a liver condition known as non-alcoholic steatohepatitis, or NASH. NASH is a type of liver disease where too much fat builds up in the liver, causing inflammation and damage. Over time, this can lead to serious problems like scarring (fibrosis) and liver failure.
The study involves a special capsule that contains healthy gut bacteria. Our gut is full of tiny living organisms, and an unhealthy balance of these can sometimes contribute to conditions like NASH. Scientists believe that introducing healthy gut bacteria might help improve liver health. In this study, some participants will receive these special capsules, while others will get a placebo, which looks identical but contains no active ingredients. This helps researchers fairly compare the new treatment to no treatment at all.
Over the course of 72 weeks (about a year and a half), the research team will closely monitor participants. They will check if the treatment helps resolve the NASH, if liver scarring gets better or stays the same, and if there are any side effects. They'll also measure overall health, including weight, blood tests, and how participants feel. This is an important step to see if this new approach could be a safe and effective treatment for NASH in the future.
Key takeaways
- The study explores a new pill with healthy gut bacteria for NASH.
- It aims to see if the pill improves liver health and is safe.
- Participants will receive either the active pill or a dummy pill.
- The study involves regular check-ups, blood tests, and scans over 72 weeks.
- This is a Phase II study, gathering more information on effectiveness and safety.
Who may be eligible?
To join this study, you must be an adult, aged 18 or older. Both men and women can take part.
You would need to have been diagnosed with non-alcoholic steatohepatitis (NASH). The study will have other specific medical criteria that determine if this particular treatment approach is suitable for you. This often includes details about your overall health and other conditions you might have.
The research team will carefully review your medical history and conduct tests to make sure you fit all the requirements for the study. It's important to discuss your full health background with the study doctors to see if this study is right 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?
- Have you been diagnosed with non-alcoholic steatohepatitis (NASH)?
- Are you able to commit to regular clinic visits for about 18 months?
- Are you able to take capsules as prescribed?
What does participation involve?
If you decide to take part, you would be randomly assigned to receive either the active treatment capsules (containing healthy gut bacteria) or a placebo (a dummy capsule). Neither you nor the study doctors would know which you are receiving – this is called a 'double-blind' study and helps ensure the results are unbiased.
Over 72 weeks (about 18 months), you would have regular visits to the clinic. These visits would include blood tests, checks of your vital signs (like blood pressure), and possibly imagining scans like an MRI to look at your liver. You would also be asked to complete questionnaires about your health and how you are feeling. Throughout this time, you would take the study capsules as instructed by the research team. Every step of the way, the study team will be there to explain what's involved and answer any questions you have.
Potential risks and benefits
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Common questions
What is NASH?
NASH stands for non-alcoholic steatohepatitis. It's a liver condition where too much fat builds up in the liver, causing inflammation and damage that can lead to scarring.
What is 'faecal microbiota transfer in capsule form'?
It's a treatment where healthy gut bacteria are taken from a donor and put into a capsule. The idea is to improve your gut's bacterial balance, which might help your liver.
What is a 'placebo'?
A placebo is a dummy pill that looks just like the real treatment but contains no active ingredients. It helps researchers fairly compare the new treatment against no treatment.
How long will the study last?
The study treatment and monitoring will last for 72 weeks, which is about a year and a half.
Can I stop taking part if I change my mind?
Yes, you have the right to leave the study at any time, for any reason, and it will not affect your routine medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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