Cure8 trial brief
A microbiome-targeted, food-grade supplement could offer a non-immunosuppressive option for people with mild-to-moderate ulcerative colitis who remain inflamed or want to delay immunosuppressive/biologic therapy. The trial also collects stool microbiome data to look for predictors of response.
Adults with mild-to-moderate ulcerative colitis, clinicians who treat UC, and researchers interested in microbiome-targeted therapies and biomarkers.
This trial enrolls about 162 adults with objectively active mild-to-moderate ulcerative colitis and randomizes them 1:1 to the supplement or placebo for 24 weeks. Participants may continue stable 5-ASA (mesalamine) or be off IBD therapy per eligibility; patients on recent advanced therapies or corticosteroids are excluded.
The primary endpoint is a composite of symptom and biomarker improvement (including fecal calprotectin ≤250 µg/g) plus no treatment escalation or colectomy through Week 24. Secondary and exploratory endpoints include endoscopic improvement, deeper biomarker remission, quality-of-life change, and stool microbiome and metabolomics analyses.
The study is a proof-of-concept Phase 2b designed to be high-signal with enrichment for objectively active disease and centralized blinded assessments. Safety oversight includes an independent Data Safety Monitoring Board and an Endpoint Adjudication Committee.
This is a registered Phase 2b proof-of-concept trial (not yet recruiting at time of record). Results are not reported here; the record describes trial design, endpoints, and planned analyses. As a clinical trial record, it details planned methods but does not present outcomes or efficacy data.
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.
If donor ethnicity or specific microbial/metabolite signatures influence FMT success, results could help identify optimal donors or develop targeted microbiota-based treatments for ulcerative colitis.
A dietary multi-mineral supplement is being tested in a Phase 2 trial to see if it can improve symptoms, influence inflammation biomarkers, and help induce or maintain remission in people with ulcerative colitis.
Hospitalized patients with acute severe ulcerative colitis often need rescue therapy to avoid colectomy.
