BridgeMD
Prospective multicenter randomized controlled double-blind label study of the prophylaxis of recurrent pouchitis after fecal microbiota transplant in UC with ileo-anal anastomosis.
EU CTIS ID: 2024-517078-52-00
What this study is testing
To compare the relapse delay after fecal microbiota transplantation versus sham transplatation for recurrent pouchitis in IPAA for ulcerative colitis.
- Therapeutic confirmatory (Phase III)
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
- Male or female ≥ 18 years at the time of signing the informed consent form (ICF).
- Subject must understand and voluntarily sign an ICF prior to conduct the study related assessments/procedure
- Willing and able to adhere to the study visit scheduled and other protocol requirements
- Subjects must have been operated with ileal pouch anal anastomosis (IPAA) with a duration of at least 6 month prior the screening visit.
- Subject must have a diagnosis of recurrent pouchitis defined as at least 2 episodes in the last year or relapsing immediately after a reasonable response to antibiotherapy (the antifungal medication is allowed until the day before transplantation).
- Subject must be in remission with a Pouchitis Disease Activity Index (PDAI) < 7 at the screening
You likely can't join if
- Crohn disease or indeterminate colitis
- Pregnant female or breastfeeding
- Chronic medical or psychiatric disease that may interfere with subject’s ability to comply with study procedures
- Administration of investigational drug within 3 months prior to planned FMT
- Adults under guardianship, Safeguard justice or trusteeship
- Subject with difficulty in follow-up (vacation, job transfer, geographical distance, lack of motivation).
See the full eligibility criteria
- Male or female ≥ 18 years at the time of signing the informed consent form (ICF).
- Subject must understand and voluntarily sign an ICF prior to conduct the study related assessments/procedure
- Willing and able to adhere to the study visit scheduled and other protocol requirements
- Subjects must have been operated with ileal pouch anal anastomosis (IPAA) with a duration of at least 6 month prior the screening visit.
- Subject must have a diagnosis of recurrent pouchitis defined as at least 2 episodes in the last year or relapsing immediately after a reasonable response to antibiotherapy (the antifungal medication is allowed until the day before transplantation).
- Subject must be in remission with a Pouchitis Disease Activity Index (PDAI) < 7 at the screening
- Subject must affiliation with social security system or beneficiary from such system
- Female of childbearing potential must have a negative pregnancy test at screening and must agree to practice effective methods of contraception
- Crohn disease or indeterminate colitis
- Pregnant female or breastfeeding
- Chronic medical or psychiatric disease that may interfere with subject’s ability to comply with study procedures
- Administration of investigational drug within 3 months prior to planned FMT
- Adults under guardianship, Safeguard justice or trusteeship
- Subject with difficulty in follow-up (vacation, job transfer, geographical distance, lack of motivation).
- Patients with contraindication to colonoscopy or anesthesia (if necessary)
- Anastomotic stenosis
- Subject with prior treatment by probiotic within 3 month prior to the transplantation visit
- Subject with prior treatment by corticosteroids within 6 weeks prior to the transplantation visit
- Subject with prior treatment by immunosuppressors within 3 month prior to the transplantation visit
- Prior treatment with a biologic within 3 month prior the transplantation visit
- Documented active infection of any kind in the last 6 months likely to require anti- infective treatment during the next months
- Absolute neutrophil count (ANC) < 1.5 x 109 /L (1,500 mm3)
- Infection with chronic HIV
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, 65+ years, 18-64 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.