Cure8 trial brief
Early, noninvasive stool tests (fecal calprotectin and FIT) might identify whether vedolizumab or infliximab is likely to work within weeks instead of months. That could let patients and clinicians make treatment decisions sooner.
Adults with moderate-to-severe ulcerative colitis starting vedolizumab or infliximab; clinicians prescribing or monitoring biologics; researchers studying IBD biomarkers.
This is a prospective, multicenter observational cohort enrolling about 100 adults (ages 18–75) with moderate-to-severe UC who are starting vedolizumab or infliximab. Stool tests (FC and FIT) will be measured at Week 2 and Week 4; the main clinical endpoint is remission at Week 14 (Full Mayo Score ≤2).
The protocol excludes pregnant people and those with contraindications to biologics. The study is recruiting at Qilu Hospital of Shandong University in China and appears to focus on real-world early biomarker response rather than testing a new drug.
Results, timing, and how predictive early changes will be remain to be seen; this record describes planned measurements and outcomes but does not report results.
This is a registered, recruiting observational cohort (planned N=100) that describes its design and endpoints but does not report findings. As an observational study it can show associations but not definitive causation.
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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