Health TrialsbyHealthPanel

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

ConditionsUlcerative Colitis (UC)Fecal CalprotetinFIT
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorQilu Hospital of Shandong University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pregnancy/lactation

Contraindications to biologics (e.g., active TB, severe infection)

Experimental drug use within 4 weeks prior to baseline

Trial population

UC patinets accept biologics

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • fecal calprotectin

    Diagnostic test

    patients will accpet test of FC combine FIT

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: UC patients accept therapy of biologics1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
WEEK 14

Secondary outcomes

1

Mucosal healing (MES=0) at W52

Clinical response rate (W14) * Endoscopic improvement (MES ≤1) at W14 * Steroid-free clinical remission at W52 * Mucosal healing (MES=0) at W52 * ROC analysis of FC/FIT for predicting outcome

Time frame
week 52

Other outcomes

Sponsors and contacts

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Qilu Hospital of Shandong University

Lead sponsor

Qilu Hospital of Shandong University (Qingdao)

Collaborator

Dezhou Hospital Qilu Hospital of Shandong University

Collaborator

Weihai Municipal Hospital

Collaborator

Liaocheng People's Hospital

Collaborator

Jining First People's Hospital

Collaborator

Source ClinicalTrials.gov
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