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Fecal biOmarker Response Evaluation for Super-Early Efficacy in Ulcerative Colitis

NCT07111572 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-08-08

No results posted yet for this study

Summary

This multicenter prospective cohort aims to evaluate whether combined changes in fecal calprotectin (FC) and fecal immunochemical test (FIT) at \*\*Week 2 and Week 4\*\* after initiating biologic therapy (vedolizumab or infliximab) can predict clinical response at \*\*Week 14\*\* and mucosal healing at \*\*Week 52\*\* in moderate-to-severe ulcerative colitis (UC) patients. Primary outcome: clinical remission rate at Week 14.

Conditions

  • Ulcerative Colitis (UC)
  • Fecal Calprotetin
  • FIT

Interventions

DIAGNOSTIC_TEST

fecal calprotectin

patients will accpet test of FC combine FIT

Sponsors & Collaborators

  • Qilu Hospital of Shandong University (Qingdao)

    collaborator OTHER

  • Dezhou Hospital Qilu Hospital of Shandong University

    collaborator OTHER

  • Weihai Municipal Hospital

    collaborator OTHER

  • Liaocheng People's Hospital

    collaborator OTHER

  • Jining First People's Hospital

    collaborator OTHER

  • 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
2026-08-01
Completion
2026-12-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07111572 on ClinicalTrials.gov