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REBALANCE UC : impact of Fecal Microbiota Transplantation in ulcerative colitis:a randomized, sham controlled trial
EU CTIS ID: 2024-511863-27-01
What this study is testing
Compare in patient with ulcerative colitis who achieved clinical remission using systemic corticosteroids, the efficacy of fecal microbiota transplantation vs sham-transplantation on steroid-free clinical and endoscopic remission at week 12.
- Phase II and Phase III (Integrated)
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
- Age ≥ 18 years and < 75 years
- Ulcerative colitis (according to the Lennard-Jones criteria) diagnosed for at least 3 months and: - Currently active (PMC score > 1) and planned to be treated by systemic corticosteroids (minimum 40mg prednisone equivalent daily) or - Currently treated by systemic corticosteroid (minimum 40mg prednisone equivalent daily) within maximum 3 weeks or "REBALANCE UC" protocol, version 12-0 of 04/07/2024 8/63 This document is the property of DRCI / APHP. All reproduction is strictly prohibited. Version date: January 2017 - Steroid dependent patients (at least one unsuccessful attempt to discontinue steroid within the last 6 months before inclusion)
- Female of child-bearing age with an active contraception and this during at least the period of treatment until the end of active follow-up period (week 24)
- Patient with health insurance (AME except)
- Informed Written consent
You likely can't join if
- UC Complication requiring surgical treatment
- Patient treated with high dose corticosteroid more than three weeks before inclusion (≥40mg prednisone equivalent daily) except in case of steroid-dependence
- Contraindication to colonoscopy or anesthesia
- Pregnancy or breastfeeding (see definitions in annex C of the protocol)
- Treatment preceding the colonoscopy with: - intravenous infliximab and/or vedolizumab and/or ustekinumab (< 6 weeks before the planned date of the colonoscopy) and/or subcutaneous infliximab (<2 weeks before the planned date of the colonoscopy), and /or adalimumab (<2 weeks before the planned date of the colonoscopy) and/or golimumab and/or tofacitinib (<4 weeks before the planned date of the colonoscopy) - immunosuppressant (thiopurine, methotrexate, tacrolimus or other classical immunosuppressant) started or stopped < 3 months before the planned date of the colonoscopy - Antibiotics, antifungic or probiotics treatment < 4 weeks before the planned date of the colonoscopy
- Participation in any other interventional study
See the full eligibility criteria
- Age ≥ 18 years and < 75 years
- Ulcerative colitis (according to the Lennard-Jones criteria) diagnosed for at least 3 months and: - Currently active (PMC score > 1) and planned to be treated by systemic corticosteroids (minimum 40mg prednisone equivalent daily) or - Currently treated by systemic corticosteroid (minimum 40mg prednisone equivalent daily) within maximum 3 weeks or "REBALANCE UC" protocol, version 12-0 of 04/07/2024 8/63 This document is the property of DRCI / APHP. All reproduction is strictly prohibited. Version date: January 2017 - Steroid dependent patients (at least one unsuccessful attempt to discontinue steroid within the last 6 months before inclusion)
- Female of child-bearing age with an active contraception and this during at least the period of treatment until the end of active follow-up period (week 24)
- Patient with health insurance (AME except)
- Informed Written consent
- UC Complication requiring surgical treatment
- Patient treated with high dose corticosteroid more than three weeks before inclusion (≥40mg prednisone equivalent daily) except in case of steroid-dependence
- Contraindication to colonoscopy or anesthesia
- Pregnancy or breastfeeding (see definitions in annex C of the protocol)
- Treatment preceding the colonoscopy with: - intravenous infliximab and/or vedolizumab and/or ustekinumab (< 6 weeks before the planned date of the colonoscopy) and/or subcutaneous infliximab (<2 weeks before the planned date of the colonoscopy), and /or adalimumab (<2 weeks before the planned date of the colonoscopy) and/or golimumab and/or tofacitinib (<4 weeks before the planned date of the colonoscopy) - immunosuppressant (thiopurine, methotrexate, tacrolimus or other classical immunosuppressant) started or stopped < 3 months before the planned date of the colonoscopy - Antibiotics, antifungic or probiotics treatment < 4 weeks before the planned date of the colonoscopy
- Participation in any other interventional study
- Patients under legal protection.
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, 18-64 years, 65+ 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.