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

Summary

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.

Conditions

• Ulcerative Colitis (UC)
• Fecal Calprotetin
• FIT
• Biomarker

Interventions

DIAGNOSTIC_TEST

FC and FIT TEST at WEEK0 2 4

FC and FIT TEST at WEEK0 2 4

Sponsors & Collaborators

• Qilu Hospital of Shandong University (Qingdao)

  collaborator OTHER

• Dezhou Hospital Qilu Hospital of Shandong University

  collaborator OTHER

• JiNing NO.1 People Hospital

  collaborator UNKNOWN

• Zaozhuang Municipal Hospital

  collaborator OTHER

• caoxian chinese medicine hospital

  collaborator UNKNOWN

• longkou chinsese medicine hospital

  collaborator UNKNOWN

• Shouguang people's Hospital

  collaborator UNKNOWN

• Weihai Municipal Hospital

  collaborator OTHER

• Liaocheng People's Hospital

  collaborator OTHER

• ZhangQiu Yile Hospital

  collaborator UNKNOWN

• Qilu Hospital of Shandong University

  lead OTHER

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-01

Primary Completion

2026-08-31

Completion

2026-12-30

Countries

• China

Study Locations