About this trial
This multicenter prospective cohort study aims to evaluate whether a \>50% decrease or normalization of both quantitative fecal immunochemical test (qFIT) and fecal calprotectin (FC) levels at 2 weeks after starting conventional therapy (mesalazine or corticosteroids) can predict clinical relapse or need for biologic/JAK inhibitor therapy escalation by 52 weeks in biologic-naive patients with active ulcerative colitis (UC). Secondary objectives include assessing predictive value at 4 weeks, building dynamic prediction models, conducting health economic evaluation (Number Needed to Test, NNT), and exploring baseline predictors of early biomarker response. Patients will be observed during standard care with stool samples collected at Weeks 0, 2, and 4. Biomarker results will be blinded to clinicians/patients until study completion.
Eligibility criteria
Qualifiers
Age 18-75 years.
Established diagnosis of Ulcerative Colitis (UC) confirmed by clinical, endoscopic, and histopathological criteria.
Endoscopic disease activity (Mayo Endoscopic Subscore ≥ 2) confirmed by colonoscopy during screening.
Biologic-naive (no prior exposure to any biologic agent [e.g., infliximab, adalimumab, vedolizumab, ustekinumab] or JAK inhibitor).
Disqualifiers
Diagnosis or high suspicion of Crohn's disease, ischemic colitis, infectious colitis, radiation colitis, intestinal tuberculosis, or other types of colitis.
Untreated systemic conditions that may cause intestinal bleeding (e.g., thrombocytopenia [PLT <50 x 10^9/L], severe coagulopathy).
Regular use of antiplatelet agents (e.g., aspirin, clopidogrel) or anticoagulants (e.g., warfarin, rivaroxaban).
Pregnancy or lactation.
Trial design
Treatments tested in this trial
- FC and FIT TEST at WEEK0 2 4
Treatment groups
Sponsors and collaborators
Qilu Hospital of Shandong University
Lead sponsor
Qilu Hospital of Shandong University (Qingdao)
Collaborator
Dezhou Hospital Qilu Hospital of Shandong University
Collaborator
JiNing NO.1 People Hospital
Collaborator
Zaozhuang Municipal Hospital
Collaborator
caoxian chinese medicine hospital
Collaborator
longkou chinsese medicine hospital
Collaborator
Shouguang people's Hospital
Collaborator
Weihai Municipal Hospital
Collaborator
Liaocheng People's Hospital
Collaborator
ZhangQiu Yile Hospital
Collaborator