Fecal biOmarker Response Evaluation for Super-Early Effic... | NCT07111572

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

NCT07111572

Sponsor

Qilu Hospital of Shandong University

Status

Not yet recruiting

Last Update Posted

Aug 8, 2025Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Ulcerative Colitis (UC)
Fecal Calprotetin
FIT

Interventions

fecal calprotectin

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2025Estimated

Primary Completion Date

Aug 1, 2026Estimated

Completion Date

Dec 1, 2026Estimated

First Submitted Date

Aug 1, 2025

First Submission Date that Met QC Criteria

Aug 1, 2025

First Posted Date

Aug 8, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 1, 2025

Last Update Posted Date

Aug 8, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

zhangyan, M.D, Qilu Hospital of Shandong UniversityPrincipal Investigator

Lead Sponsor

Qilu Hospital of Shandong UniversityOTHER

Collaborators

Name	Class
Qilu Hospital of Shandong University (Qingdao)	OTHER
Dezhou Hospital Qilu Hospital of Shandong University	OTHER
Weihai Municipal Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
UC patients accept therapy of biologics			Diagnostic Test: fecal calprotectin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
fecal calprotectin	Diagnostic Test	patients will accpet test of FC combine FIT	UC patients accept therapy of biologics

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion achieving clinical remission (Full Mayo Score ≤2, no subscore >1) at Week 14		WEEK 14

Secondary Outcomes

Measure	Description	Time Frame
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	week 52

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

UC patinets accept biologics

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yan Zhang, M.D	Contact	+86 18560089821		qlzhangyan@sdu.edu.cn

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003093	Colitis, Ulcerative

Ancestor Terms

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided