Fecal microbiota transplantation for primary sclerosing cholangitis - randomized study versus sham transplantation (FMT-SCLER).
This study is investigating a new treatment for a liver condition called Primary Sclerosing Cholangitis (PSC). It's looking at something called fecal microbiota transplantation, which involves introducing healthy gut bacteria from a donor into a patient. The aim is to see if this can improve liver function, specifically by reducing levels of a liver enzyme called ALP and also reducing levels of bilirubin. Participants will receive either the actual treatment (taken as capsules or as an enema) or a placebo (dummy treatment), and their health will be monitored over 48 weeks to understand how well the different treatments work and if they are safe.
At a glance
What is this study about?
This study is about a health problem called Primary Sclerosing Cholangitis, often shortened to PSC. PSC is a long-term disease that slowly damages the bile ducts in your liver. Bile ducts are like small tubes that carry a digestive fluid called bile from your liver to your gut. When these ducts are damaged, bile can build up in your liver and cause problems.
Researchers are exploring a treatment called 'fecal microbiota transplantation' (FMT). This involves taking healthy gut bacteria from a donor and giving it to someone with a condition like PSC. The idea is that improving the mix of bacteria in your gut might help improve your liver health. In this study, some people will get the actual FMT treatment (either as capsules you swallow or as an enema), and others will get an inactive treatment called a 'placebo', which looks and feels the same but contains no active ingredients. This helps researchers work out if the FMT is truly making a difference.
The main goal of the study is to see if FMT can improve certain liver markers, specifically reducing levels of an enzyme called ALP and also bilirubin, over 48 weeks. They are also looking at other things like how patients feel, their quality of life, and any changes in other liver tests. This is a combined Phase II and Phase III study, meaning it's testing both if the treatment works and if it's safe and effective on a larger scale.
Key takeaways
- This study is testing a new treatment called FMT for PSC.
- FMT involves transplanting healthy gut bacteria.
- It's a 'double-blind' study, meaning you might receive treatment or a placebo.
- The main goals are to check liver health markers and safety over 48 weeks.
- Participation involves regular tests and questionnaires.
Who may be eligible?
To be part of this study, you need to be an adult, 18 years old or older. There is no upper age limit, meaning older adults can also take part.
The study is open to both men and women. If you have Primary Sclerosing Cholangitis, you might be suitable for this research.
However, the full details of who can and cannot join a study are much more specific than what's listed here. Your doctor would need to check many other things about your health to see if it's safe and appropriate 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?
- Do you have Primary Sclerosing Cholangitis?
- Are you able to attend regular hospital visits and appointments?
- Are you willing to potentially receive either the active treatment or a placebo?
- Are you comfortable with blood tests and liver scans?
What does participation involve?
If you decide to take part in this study, you would receive either the active fecal microbiota transplant treatment or a placebo (dummy treatment). The active treatment could be in the form of capsules you swallow or an enema. You wouldn't know which one you're getting, and neither would your study doctor, which is called 'double-blinded'.
Your health would be closely monitored over 48 weeks. This would involve regular visits where researchers would take blood tests to check your liver function (including ALP and bilirubin levels), and perform other assessments like liver scans (elastometry and magnetic resonance cholangiography). You would also be asked to fill out questionnaires to assess your symptoms, quality of life, and any changes in bowel activity if you have inflammatory bowel disease (IBD).
Throughout the study, researchers will be looking out for any side effects or changes in your overall health. The total duration of active participation and monitoring is at least 48 weeks, with some follow-up continuing beyond that for safety.
Potential risks and benefits
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Common questions
What is Primary Sclerosing Cholangitis (PSC)?
PSC is a chronic liver disease that damages the small tubes (bile ducts) in your liver, which can lead to liver scarring and other problems.
What is fecal microbiota transplantation (FMT)?
FMT is a procedure where healthy gut bacteria are transferred from a donor into a patient, aiming to improve the patient's gut health.
Will I know if I'm getting the real treatment or a dummy treatment?
No, neither you nor your study doctor will know if you're getting the active treatment or the placebo. This is to ensure the study results are as fair as possible.
How long will I be involved in the study?
Your direct participation and monitoring will last for at least 48 weeks, with some follow-up extending beyond that time.
What kind of tests will I have during the study?
You will have regular blood tests, liver scans, and fill out questionnaires about how you're feeling and your quality of life.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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