Transfer of FRozen Encapsulated Multidonor Stool Filtrate for Active Ulcerative COlitis
This study, called FRESCO, is investigating new ways to treat active Ulcerative Colitis. This condition causes long-term inflammation in the gut. Researchers are testing two types of capsules made from healthy donor stool. One type contains helpful gut bacteria (FMT), and the other contains a filtered version of helpful gut bacteria (FMFT). These capsules are given by mouth. The study will compare these treatments to a dummy pill (placebo) to see if they can help reduce symptoms and inflammation. About 174 people with mild to moderate Ulcerative Colitis will take part. The main goal is to find out if these capsules are safe and effective in helping people achieve clinical and endoscopic remission within 12 weeks. This could lead to a new treatment option for Ulcerative Colitis.
At a glance
What is this study about?
Ulcerative Colitis is a long-term condition that causes inflammation and ulcers in the lining of the large intestine. It can lead to uncomfortable symptoms like tummy pain and diarrhoea. While current treatments exist, doctors are always looking for new and better ways to help people manage their condition. One idea is that problems with the 'good' bacteria in our gut might play a role in Ulcerative Colitis.
This study, called FRESCO, is exploring whether using healthy gut bacteria from donors could be a new treatment. We know that transferring gut bacteria from a healthy person (called faecal microbiota transplantation, or FMT) has been very successful in treating certain serious gut infections. In this study, we're trying a new approach using special capsules you take by mouth. Some capsules contain the full 'good' bacteria from donor stool, while others contain a filtered version, thought to have similar benefits without the full bacteria.
The main aim is to see if these capsules can help people with active Ulcerative Colitis achieve 'remission', meaning their symptoms improve and the inflammation in their gut calms down. The study will also carefully check for any side effects and try to understand how these treatments might work in the body. By comparing these capsules to a dummy pill, the researchers can clearly see if the treatments are actually making a difference.
Key takeaways
- This study is testing new capsule treatments for active Ulcerative Colitis.
- The capsules contain helpful gut bacteria or filtered versions from healthy donors.
- It's a comparison study, meaning some participants will receive a dummy pill (placebo).
- The main aim is to see if the capsules can reduce symptoms and inflammation.
- Participation involves taking capsules, clinic visits, and some colonoscopy checks.
- The study aims to find new, effective treatments for Ulcerative Colitis.
Who may be eligible?
To be considered for this study, you would generally need to be between 18 and 75 years old and have been diagnosed with Ulcerative Colitis for at least six months. Your condition should be considered 'active' but mild to moderate, meaning you're experiencing symptoms and inflammation, but it's not severe enough to be an emergency.
It's important that you have already tried some standard treatments for Ulcerative Colitis, such as certain oral medications, and either they haven't worked well enough, or you're already on a stable dose of these medications. You would also need to have proof of vaccination against COVID-19 or have had the infection before, or have protective antibodies.
There are also reasons why you might not be able to join. For instance, if you have Crohn's disease (another type of inflammatory bowel disease), a serious gut emergency, or have had major bowel surgery. Certain other health conditions, ongoing infections, or a recent cancer diagnosis would also prevent participation. Women who could become pregnant would need to have a negative pregnancy test and agree to use effective contraception during the study.
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 between 18 and 75 years old?
- Have you been diagnosed with Ulcerative Colitis for at least 6 months?
- Do you currently have mild to moderate active Ulcerative Colitis symptoms?
- Have you already tried some standard Ulcerative Colitis medications or are you on a stable dose?
- Are you able to regularly attend clinic appointments and undergo necessary procedures?
- If you could become pregnant, are you willing to use effective contraception during the study?
What does participation involve?
If you decide to take part in this study, you will be assigned by chance to one of three groups: one group will receive capsules with the full helpful gut bacteria, another group will receive capsules with the filtered helpful gut bacteria, and the third group will receive dummy capsules (placebo). Neither you nor your study doctor will know which group you are in. You will take these capsules by mouth.
The study involves regular visits to the clinic for assessments, which will include examinations, answering questions about your symptoms, and possibly blood and stool samples. You will also have some colonoscopy procedures, which involve a camera test of your bowel, at certain points during the study to check your progress. The main goal is to see how you are doing after 12 weeks, but the study will involve longer follow-up to monitor your condition and ensure safety. The overall duration of your participation will be discussed in detail by the study team.
Potential risks and benefits
Locations (20)
- Jena University HospitalVerified postcodeJena, Germany· Recruiting
- Sozialstiftung BambergVerified postcodeBamberg, Germany· Recruiting
- Charité BerlinVerified postcodeBerlin, Germany· Recruiting
- DRK Kliniken Berlin WestendVerified postcodeBerlin, Germany· Recruiting
- HavelhöheVerified postcodeBerlin, Germany· Recruiting
- Krankenhaus WaldfriedeVerified postcodeBerlin, Germany· Recruiting
- Universitätsklinikum Carl Gustav Carus DresdenVerified postcodeDresden, Germany· Recruiting
- FAU Universität Erlangen-NürnbergVerified postcodeErlangen, Germany· Recruiting
- Agaplesion Markus KrankenhausVerified postcodeFrankfurt, Germany· Recruiting
- Universitätsklinik FreiburgVerified postcodeFreiburg im Breisgau, Germany· Recruiting
- Klinikum FuldaVerified postcodeFulda, Germany· Recruiting
- Universitätsklinikum Halle (Saale)Verified postcodeHalle, Germany· Recruiting
Common questions
What is Ulcerative Colitis?
Ulcerative Colitis is a long-term condition where the lining of your large intestine (colon and rectum) becomes inflamed and develops tiny ulcers, causing symptoms like abdominal pain and diarrhoea.
What does 'faecal microbiota transplantation' (FMT) mean?
FMT is when 'good' bacteria from the stool of a healthy donor are transferred to another person's gut. In this study, it's given in capsule form.
What is a 'placebo'?
A placebo is a 'dummy' treatment that looks just like the real medication but contains no active drug. It helps researchers compare if the new treatment actually works better than doing nothing.
Will I know which treatment group I'm in?
No, this is a 'double-blind' study, meaning neither you nor your doctors will know if you are receiving the active treatment or the placebo until the study is over. This helps ensure fair results.
What is the goal of this study?
The main goal is to see if the special capsules made from donor stool are safe and effective in helping people with active Ulcerative Colitis achieve remission, meaning their symptoms get better and gut inflammation reduces.
How to find out more
Andreas Stallmach, Prof.
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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