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Fecal microbiota transplantation in patients receiving infliximab and vedolizumab for ulcerative colitis: A randomized controlled trial
EU CTIS ID: 2024-520373-12-00
What this study is testing
The main aim is to determine the feasibility to run a proper RCT with a larger sample size with fecal microbiota transplant (FMT) + infliximab (IFX) or FMT + vedolizumab (VDZ) since this study is a pilot study. Objectives: To assess the efficacy of FMT + IFX as compared to IFX alone. To assess the efficacy of FMT + VDZ as compared to VDZ alone. To assess the safety of FMT in patients receiving biologics for active ulcerative colitis. To assess fecal microbiota changes in patients receiving biologics as compared to patients receiving biologics and FMT.
- Therapeutic use (Phase IV)
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
- 18-75 years old
- Active ulcerative colitis or corticosteroid dependent disease and an indication for induction therapy with biological agents
- Bionaive, i.e. no previous exposure to TNF blockers, vedolizumab or other biologics
- Signed informed consent
You likely can't join if
- Previous treatment with infliximab or vedolizumab or other biologics
- Fulminant severe colitis (Truelove and Witts citeria)
- Pregnancy
- Known contraindication to infliximab or vedolizumab
- Antibiotic therapy at the baseline
- On-going probiotic medication
See the full eligibility criteria
- 18-75 years old
- Active ulcerative colitis or corticosteroid dependent disease and an indication for induction therapy with biological agents
- Bionaive, i.e. no previous exposure to TNF blockers, vedolizumab or other biologics
- Signed informed consent
- Previous treatment with infliximab or vedolizumab or other biologics
- Fulminant severe colitis (Truelove and Witts citeria)
- Pregnancy
- Known contraindication to infliximab or vedolizumab
- Antibiotic therapy at the baseline
- On-going probiotic medication
- Impaired cognition and thus unable to provide signed informed consent
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.