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

NCT ID: NCT07111572

Last Updated: 2025-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-01

Study Completion Date

2026-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Ulcerative Colitis (UC) Fecal Calprotetin FIT

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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UC patients accept therapy of biologics

fecal calprotectin

Intervention Type DIAGNOSTIC_TEST

patients will accpet test of FC combine FIT

Interventions

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fecal calprotectin

patients will accpet test of FC combine FIT

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Age 18-75 years, UC diagnosis with endoscopic Mayo score (MES) ≥2
* Moderate-to-severe activity (Full Mayo Score ≥6)
* Initiating vedolizumab or infliximab within 7 days after baseline
* Biologic-naïve or prior exposure to only one TNF-α inhibitor

Exclusion Criteria

* Pregnancy/lactation
* Contraindications to biologics (e.g., active TB, severe infection)
* Experimental drug use within 4 weeks prior to baseline
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qilu Hospital of Shandong University (Qingdao)

OTHER

Sponsor Role collaborator

Dezhou Hospital Qilu Hospital of Shandong University

OTHER

Sponsor Role collaborator

Weihai Municipal Hospital

OTHER

Sponsor Role collaborator

Liaocheng People's Hospital

OTHER

Sponsor Role collaborator

Jining First People's Hospital

OTHER

Sponsor Role collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role lead

Responsible Party

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zhangyan

M.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Yan Zhang, M.D

Role: CONTACT

+86 18560089821

Other Identifiers

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QILUGI-003

Identifier Type: -

Identifier Source: org_study_id

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