Fecal microbiota transplantation in patients receiving infliximab and vedolizumab for ulcerative colitis: A randomized controlled trial
This research is investigating a treatment approach for people living with ulcerative colitis. It combines a procedure called faecal microbiota transplant (FMT) with commonly used medications like infliximab (including Zessly and Remsima) and vedolizumab (Entyvio). The main goal is to see if this combination helps patients achieve and maintain 'remission' — meaning their symptoms are well controlled and they feel much better, without needing steroid medications. Researchers want to know if this approach helps improve gut health, reduces inflammation, and ultimately enhances the quality of life for those with ulcerative colitis. This is a later-stage study, meaning these treatments are already being used clinically in some form.
At a glance
What is this study about?
This study is for people who have ulcerative colitis or Crohn's disease, which are types of inflammatory bowel disease (IBD). Ulcerative colitis causes inflammation and sores in the lining of your large intestine. The study is trying to find out if combining a treatment called faecal microbiota transplant (FMT) with standard medications like infliximab (brand names like Zessly, Remsima) and vedolizumab (brand name Entyvio) can help people get into remission and stay there without needing steroids.
FMT involves transferring healthy gut bacteria from a donor into a patient’s gut with the aim of restoring a healthy balance of microbes. Infliximab and vedolizumab are medicines that help reduce inflammation in the gut. The researchers want to see if using these treatments together can be more effective than the medications alone.
Being in 'remission' means that your symptoms of ulcerative colitis, like stomach pain, bleeding, and frequent trips to the toilet, are significantly reduced or have gone away. The researchers will be carefully measuring whether participants reach this state by looking at their symptoms, examining their bowel using a scope, and checking other health markers. The study is particularly interested in 'steroid-free remission', which means getting better without relying on steroid medicines, as steroids can have side effects when used long-term.
Key takeaways
- This study combines faecal microbiota transplant (FMT) with common IBD medicines.
- It aims for long-lasting symptom control without steroid use in ulcerative colitis.
- Participation involves regular treatments and health check-ups.
- Researchers will monitor how well symptoms improve and quality of life.
- Adults with ulcerative colitis or Crohn's disease might be suitable.
- You can stop participating at any time.
Who may be eligible?
To be considered for this study, you need to be an adult, aged 18 or older. Both men and women can take part.
You would need to have been diagnosed with either ulcerative colitis or Crohn's disease. The study is specifically looking at how certain treatments work together for these conditions.
There might be other specific health requirements or medications you are currently taking that the study team will need to discuss with you to see if you are a good fit. They will explain everything clearly during the screening process.
- Are you 18 years old or older?
- Do you have a diagnosis of ulcerative colitis or Crohn's disease?
- Are you able to attend regular appointments for treatment and check-ups?
- Are you comfortable with receiving treatments like infusions or injections, and potentially FMT?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to join this study, you would receive treatments that include a faecal microbiota transplant (FMT) and medications like infliximab or vedolizumab. These are given either through a drip into your arm or as an injection, depending on the specific medicine. You would have regular appointments for these treatments and check-ups.
At these visits, the study team would monitor your health carefully. This would involve checking your symptoms, taking blood pressure and weight measurements, and possibly collecting stool samples. You might also have a procedure to look inside your bowel with a small camera (endoscopy) to check for healing.
The main part of the study measures how you are doing after about 12 to 14 weeks from your first treatment. However, you would continue to be monitored for longer to track your progress, check for any side effects, and see how your quality of life improves. The total duration of your involvement in the study would be explained in detail by the research team.
Potential risks and benefits
Locations (1)
- —Finland
Common questions
What is faecal microbiota transplant (FMT)?
FMT is a procedure where healthy gut bacteria from a screened donor are transferred into the gut of a patient to help restore a healthy balance of microbes.
What are infliximab and vedolizumab?
These are medicines used to treat inflammatory bowel diseases like ulcerative colitis, by helping to reduce inflammation in the bowel.
What does 'steroid-free clinical remission' mean?
It means your ulcerative colitis symptoms are significantly improved or gone, and you don't need to take steroid medicines to control them.
What is the 'Mayo scale'?
The Mayo scale is a scoring system doctors use to assess the severity of ulcerative colitis based on symptoms and how the bowel looks inside.
Will taking part in this study affect my usual healthcare?
No, your decision to participate or not, and your right to withdraw at any time, will not affect the standard medical care you receive.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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