DYNAMIC-UC: Early qFIT and Calprotectin Change Predicting Relapse in Biologic-Naive Ulcerative Colitis

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorQilu Hospital of Shandong University

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

No treatment groups listed

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