Fecal microbiota transplantation in patients receiving infliximab and vedolizumab for ulcerative colitis: A randomized controlled trial

Brief summary (registry, in English)

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.

What you commit to

• Study type: Interventional · Phase 4
• Planned participants: 40
• 3 sites in 1 country
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

AI-kivonat: who the study is looking for

Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with active ulcerative colitis who have never had biologic drugs and need to start one.

Age

18 to 75 years

Sex

All sexes can join.

Disease stage

Active ulcerative colitis, or colitis that needs corticosteroids to stay controlled, with an indication for starting treatment with biological agents.

Earlier treatment

No earlier exposure to TNF blockers, vedolizumab or other biologics. No antibiotics or probiotics at the start.

Main reasons for not taking part

• Earlier treatment with infliximab, vedolizumab or other biologics
• Fulminant severe colitis (Truelove and Witts criteria)
• Pregnancy
• Known contraindication to infliximab or vedolizumab
• Impaired cognition, unable to give signed informed consent

Read by machine on 9 Nov 2026.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (3)

Sites in registry order. Save your city in your profile to sort them by distance.

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