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Oral Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis (UC)
EU CTIS ID: 2024-518044-20-00
What this study is testing
Success of FMT with frozen stool capsules defined by an increase in the richness of the recipient's microbiota at 6 months.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patient aged 8 to 17 years old
- Ulcerative colitis (UC), whatever the extent, except isolated proctitis (<5 cm), diagnosed for more than 3 months according to the usual clinical, biological and endoscopic criteria.
- Moderate active UC defined by a PUCAI score > 35 and responding to corticosteroid treatment with a PUCAI score <10 at enrolment
- Treatment of UC (5-ASA, immunosuppressants, biotherapies) stable for more than 3 months
- Patient able to swallow test capsules
- For girls of childbearing age: To have a negative blood (or urine) pregnancy test To agree to use a reliable contraceptive method from visit 1 until the end of the research
You likely can't join if
- Isolated proctitis (<5 cm)
- Being on enteral nutrition
- Have received antibiotic or antifungal treatment in the 4 weeks prior to enrolment
- Having a Clostridioides difficile infection in the 4 weeks prior to enrolment;
- Being pregnant or breastfeeding, or have a positive pregnancy test
- Participation in other interventional research involving humans
See the full eligibility criteria
- Patient aged 8 to 17 years old
- Ulcerative colitis (UC), whatever the extent, except isolated proctitis (<5 cm), diagnosed for more than 3 months according to the usual clinical, biological and endoscopic criteria.
- Moderate active UC defined by a PUCAI score > 35 and responding to corticosteroid treatment with a PUCAI score <10 at enrolment
- Treatment of UC (5-ASA, immunosuppressants, biotherapies) stable for more than 3 months
- Patient able to swallow test capsules
- For girls of childbearing age: To have a negative blood (or urine) pregnancy test To agree to use a reliable contraceptive method from visit 1 until the end of the research
- Patient with health insurance
- Informed written consent form signed by both parents or by the person (s) with parental authority
- Isolated proctitis (<5 cm)
- Being on enteral nutrition
- Have received antibiotic or antifungal treatment in the 4 weeks prior to enrolment
- Having a Clostridioides difficile infection in the 4 weeks prior to enrolment;
- Being pregnant or breastfeeding, or have a positive pregnancy test
- Participation in other interventional research involving humans
- Have a contraindication to colonoscopy or general anaesthesia
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.