NCT07111572

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Aug 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress57%
Aug 2025Dec 2026

First Submitted

Initial submission to the registry

August 1, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 8, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

August 8, 2025

Status Verified

August 1, 2025

Enrollment Period

1 year

First QC Date

August 1, 2025

Last Update Submit

August 1, 2025

Conditions

Ulcerative Colitis (UC)Fecal CalprotetinFIT

Keywords

UCfecal calprotectinFIT

Outcome Measures

Primary Outcomes (1)

  • Proportion achieving **clinical remission** (Full Mayo Score ≤2, no subscore >1) at **Week 14**

    WEEK 14

Secondary Outcomes (1)

  • Mucosal healing (MES=0) at W52

    week 52

Study Arms (1)

UC patients accept therapy of biologics

Diagnostic Test: fecal calprotectin

Interventions

fecal calprotectinDIAGNOSTIC_TEST

patients will accpet test of FC combine FIT

UC patients accept therapy of biologics

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

UC patinets accept biologics

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Central Study Contacts

Yan Zhang, M.D

CONTACT

+86 18560089821qlzhangyan@sdu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D

Study Record Dates

First Submitted

August 1, 2025

First Posted

August 8, 2025

Study Start

August 1, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

August 8, 2025

Record last verified: 2025-08