Fecal microbiota transplantation in patients receiving infliximab and vedolizumab for ulcerative colitis: A randomized controlled trial
Key facts
- Where
- Helsinki, Lahti és Turku, FinnországSee the 3 sites
- Phase
- 4. fázis
Where in Finnország
- HUS-YhtymaeHelsinki, FinnországToborzás még nem indult
- Paeijaet-Haemeen hyvinvointialueLahti, FinnországToborzás még nem indult
- Varsinais-Suomen hyvinvointialueTurku, FinnországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Varsinais-Suomen hyvinvointialue
- Trial code
- EU 2024-520373-12-00
- Record updated
- 2025. január 21.
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: Previous treatment with infliximab or vedolizumab or other biologics; Antibiotic therapy at the baseline; On-going probiotic medication; Fulminant severe colitis (Truelove and Witts citeria); Pregnancy; Known contraindication to infliximab or vedolizumab; Impaired cognition and thus unable to provide signed informed consent.