Fecal transplant for ulcerative colitis in children
Part of Digestive system clinical trials.
This trial tests whether giving children with ulcerative colitis a transplant of healthy donor stool (fecal microbiota transplant) can help control their disease. It aims to see if this treatment can reduce inflammation in the gut.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You must be between 8 and 17 years old.
- You must have ulcerative colitis (a type of inflammatory bowel disease) for at least 3 months, but not limited to inflammation in the very last part of the rectum (unless it's short).
- Your disease must be moderately active and you must be responding well to corticosteroids, with a disease activity score below 10 at the start.
- Your current ulcerative colitis treatments (like 5-ASA, immunosuppressants, or biologics) must have been stable for at least 3 months.
- You must be able to swallow capsules by mouth.
- If you are a girl who can have children, you need a negative pregnancy test and must agree to use reliable birth control during the trial.
- You must have French health insurance and your parent(s) or legal guardian(s) must sign a consent form.
- You cannot have taken antibiotics or antifungal medicines in the 4 weeks before starting, and you must not have had a Clostridioides difficile infection recently.
- You cannot be on tube feeding (enteral nutrition), pregnant, or breastfeeding.
- You must not have any reason that makes a colonoscopy or general anesthesia unsafe.
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
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This trial studies whether transferring healthy stool bacteria into the gut (fecal microbiota transplantation, or FMT) can improve symptoms in children with ulcerative colitis. It may help by changing gut bacteria, especially for children who are newly diagnosed or who didn’t respond to standard treatments.
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