Cure8 trial brief
Faecal microbiota transfer is being tested in a large Phase 3 trial as a possible new treatment approach for active ulcerative colitis, and this study also looks at safety and how the therapy changes the gut microbiome and inflammation.
If effective, oral capsule FMT/FMFT could offer a noninvasive microbiome-targeted option for people with UC who have not responded to other therapies.
Adult patients with mild-to-moderate ulcerative colitis, gastroenterologists and IBD clinicians, researchers studying microbiome therapies, and patients interested in noninvasive microbiome-based treatments.
This is a Phase 3 randomized, double-blind, three-arm multicentre trial (FRESCO) testing repeated oral frozen capsules of faecal microbiota transplantation (FMT) or faecal microbiota filtrate transplantation (FMFT) versus placebo in adults with mild-to-moderate active ulcerative colitis.
The primary outcome is clinical and endoscopic remission at 12 weeks (Mayo score-based). The interventions use multidonor stool processed into either whole microbiota capsules or filtrate capsules, given as two sets of five frozen capsules daily on 5 consecutive days per week for 12 weeks.
The study will also examine safety and microbial and inflammatory changes after FMT/FMFT to understand mechanisms. Eligible patients must have prior endoscopic confirmation of UC, a Mayo score 4–10, and have failed conventional therapy or been treated with biologics/small molecules; several immunosuppressive or recent biologic/JAK/S1P therapies are excluded.
Practical points: this is a registered, active (not recruiting) Phase 3 interventional trial listed on ClinicalTrials.gov with planned enrollment and detailed inclusion/exclusion criteria. It describes administration logistics (oral, frozen hypromellose capsules) and defines primary outcome timing and remission criteria.
This record is a clinical trial registration (Phase 3) on ClinicalTrials.gov. It describes planned interventions, eligibility, and outcomes but does not report results. As with any trial registration, outcomes and safety findings require peer-reviewed publication or registry results to judge efficacy and risks.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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