T-FORE - Pilot study of a new technique of Oral Fecal Transplantation using frozen stool capsules for the maintenance treatment of pediatric Ulcerative Colitis (UC)
This research, called T-FORE, is a pilot study exploring a new treatment for children with Ulcerative Colitis (UC). UC is a long-term condition that causes inflammation in the large intestine. The study focuses on a treatment called Faecal Microbiota Transplantation (FMT), which involves transferring healthy gut bacteria from a donor’s stool into a patient. Researchers are testing two methods: taking frozen stool in capsules by mouth, or receiving it as an enema. The main goal is to see if these treatments can increase the variety of good bacteria in the child’s gut over 6 to 12 months. This could help manage UC and improve their health. It's a small, early-stage study to learn more about these new approaches.
At a glance
What is this study about?
This study, called T-FORE, is looking into a new way to help children who have a condition called Ulcerative Colitis (UC). UC is a type of inflammatory bowel disease where the lining of the large intestine (colon) becomes inflamed and develops tiny sores, leading to symptoms like tummy pain, bloody stools, and tiredness.
The study is testing a treatment called Faecal Microbiota Transplantation (FMT). This involves taking healthy gut bacteria from a healthy donor's stool and giving it to someone with UC. The idea is to replace the unhealthy balance of bacteria in the patient's gut with a healthier mix, which might help to calm the inflammation. Researchers are trying out two different ways to give this treatment: either by having children swallow special capsules containing the frozen stool, or by giving it as an enema (liquid medication inserted into the rectum).
The main aim of this study is to see if these treatments can successfully increase the 'richness' or variety of beneficial bacteria in the child's gut over 6 to 12 months. A more diverse and balanced gut microbiome is often linked to better health. If the treatments successfully improve the gut's bacterial balance, it could be a promising step towards better ways to manage Ulcerative Colitis in children. This is an early-stage or 'pilot' study, meaning it's a first look to see if the treatment is safe and shows potential.
Key takeaways
- This study explores a new treatment for children with Ulcerative Colitis.
- It uses healthy donor stool to try and rebalance gut bacteria.
- Two methods are being tested: capsules and enemas.
- The main goal is to see if the treatment increases the variety of good gut bacteria.
- It's an early-stage study to gather initial safety and effectiveness information.
- Participation involves ongoing monitoring and stool sample collection over 12 months.
Who may be eligible?
To join this study, children of any age who have Ulcerative Colitis may be considered. Both boys and girls are welcome to take part.
The research team will carry out detailed checks to make sure the study is suitable and safe for each child. This will involve reviewing their medical history and current health to determine if they meet all the specific requirements for participation.
It’s important to remember that even if a child has Ulcerative Colitis, there might be other reasons why they can’t join the study. The research team will explain all the details clearly.
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.
- My child has been diagnosed with Ulcerative Colitis.
- My child is a boy or a girl.
- My child is within the age range being considered for the study (any age).
- I understand the study involves receiving donor stool either orally or via enema.
- I am comfortable with my child having regular follow-up appointments and tests.
What does participation involve?
If your child takes part in this study, they will receive either frozen stool capsules to take by mouth or a stool enema. The study will involve regular visits to the clinic over a period of time, likely at 0, 6, and 12 months, where doctors will collect stool samples to check the types of bacteria in your child's gut. They will also do colonoscopies at the start and at 12 months to get a closer look at the gut lining and collect samples. The total duration of your child's involvement in the study will be at least 12 months, with follow-up appointments and tests to see how the treatment is affecting their gut bacteria.
Potential risks and benefits
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Common questions
What is Ulcerative Colitis?
Ulcerative Colitis is a long-term condition that causes inflammation and sores in the lining of the large intestine (colon).
What is 'Faecal Microbiota Transplantation' (FMT)?
FMT is a treatment where healthy bacteria from a donor's stool are transferred into a patient's gut to improve their gut health.
How will the treatment be given?
Participants will either take special capsules containing frozen stool by mouth or receive the treatment as an enema (liquid through the bottom).
Why are they studying gut bacteria?
Researchers believe that an unhealthy balance of gut bacteria may play a role in Ulcerative Colitis, and improving this balance could help the condition.
What is a 'pilot study'?
A pilot study is a small, early-stage study designed to see if a new treatment is safe and shows promise before larger studies are done.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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