Fecal biOmarker Response Evaluation for Super-Early Efficacy in Ulcerative Colitis
Observational · No treatment assigned · 1 site · Qilu Hospital of Shandong University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Ulcerative Colitis (UC), Fecal Calprotetin and FIT. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- 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
Plus 5 more requirement(s). Only the trial team can confirm whether you qualify.
What's involved
- About 100 participants are expected to take part.
- Start date: 2025-08-01.
- Main results expected around 2026-08-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in China.
Main thing being measured
- Proportion achieving **clinical remission** (Full Mayo Score ≤2, no subscore >1) at **Week 14** (WEEK 14)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Ulcerative Colitis (UC); Fecal Calprotetin; FIT |
| Lead sponsor | Qilu Hospital of Shandong University |
| Collaborators | Qilu Hospital of Shandong University (Qingdao); Dezhou Hospital Qilu Hospital of Shandong University; Weihai Municipal Hospital; Liaocheng People's Hospital; Jining First People's Hospital |
| Enrollment | 100 (estimated) |
| Start date | 2025-08-01 |
| Primary completion (est.) | 2026-08-01 |
| First posted | 2025-08-08 |
| Last updated | 2026-07-28 |
| Official title | Dynamic Changes of Fecal Calprotectin and Fecal Immunochemical Test for Early Prediction of Biologic Treatment Efficacy in Ulcerative Colitis: A Multicenter, Prospective Cohort Study |
| ClinicalTrials.gov ID | NCT07111572 |
Interventions
- fecal calprotectin (Diagnostic Test)
patients will accpet test of FC combine FIT
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Qilu Hospital of Shandong University | Jinan, Shandong | China | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.