Cure8 trial brief
Early changes in stool tests (qFIT and fecal calprotectin) might help predict which biologic‑naive ulcerative colitis patients will relapse or need escalation to biologic/JAK therapy. If validated, such markers could guide earlier treatment decisions and could be cost‑effective.
Adults with UC starting mesalazine or steroids; gastroenterologists and IBD clinicians; researchers in biomarkers and clinical prediction; patients interested in noninvasive monitoring.
This ClinicalTrials.gov registry describes a multicenter prospective observational cohort (DYNAMIC-UC) enrolling biologic‑naive adults with active ulcerative colitis who start conventional therapy (oral/rectal mesalazine or systemic corticosteroids).
The study will collect stool at baseline, Week 2, and Week 4 to measure quantitative fecal immunochemical test (qFIT) and fecal calprotectin (FC), with results blinded to clinicians until study end.
The primary goal is to test whether a >50% decrease or normalization of both qFIT and FC at 2 weeks predicts clinical relapse or escalation to biologic/JAK therapy by 52 weeks.
The registry lists planned secondary analyses including prediction modeling (AUC, sensitivity/specificity), health‑economic calculations (number needed to test), and evaluation of baseline predictors of early biomarker response. The study is recruiting, plans to enroll about 100 participants, and is being conducted at Shandong University sites in China.
If you are a patient or clinician, this trial is focused on early stool biomarker changes (qFIT and FC) after starting mesalazine or steroids, not on testing a new drug. Biomarker results are blinded during follow‑up and the study observes standard clinical care with predefined criteria for ‘‘treatment escalation’’ to biologics or JAK inhibitors.
This is a clinicaltrials.gov study record (observational, recruiting) describing planned research methods and endpoints; it does not report results. Biomarker assays are measured but blinded to treating clinicians during the study.
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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