NCT07111572招募中不适用
Dynamic Changes of Fecal Calprotectin and Fecal Immunochemical Test for Early Prediction of Biologic Treatment Efficacy in Ulcerative Colitis: A Multicenter, Prospective Cohort Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Proportion achieving **clinical remission** (Full Mayo Score ≤2, no subscore >1) at **Week 14**
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Pregnancy/lactation
- •Contraindications to biologics (e.g., active TB, severe infection)
- •Experimental drug use within 4 weeks prior to baseline
研究组 & 干预措施
UC patients accept therapy of biologics
干预措施: fecal calprotectin (Diagnostic Test)
结局指标
主要结局
Proportion achieving **clinical remission** (Full Mayo Score ≤2, no subscore >1) at **Week 14**
时间窗: WEEK 14
次要结局
- Mucosal healing (MES=0) at W52(week 52)
研究者
Yan Zhang, MD
M.D
Qilu Hospital of Shandong University
研究点 (1)
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