Predictive Factors of Anti-TNFalfa-induced Deep Remission in Crohn's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Number of IBD patients in clinical remission at 12 months
研究概览
简要总结
Individuate possible predictive factors of anti-TNFalfa-induced deep remission in Crohn's disease.
详细描述
This trial will be exploratory, open in vitro study on human tissues. 120 patients will be enrolled (Caucasian, male/female,18-65 years old) with moderate-severe active Crohns disease and with indication for anti-TNF therapy according to the normal clinical practice.
Simultaneously, 30 no-IBD controls with no GI disorders, as defined by medical history and standard clinical chemistry values, afferent to the out-patient clinic will be enrolled.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of IBD patients in clinical remission at 12 months
时间窗: 12 months
* Subjects without intestinal ulceration at endoscopy at 12 months * Subjects with CDAI score below 150 from baseline to 12 months * Subjects with blood CRP value below 0.8 mg/dL from baseline to 12 months * Subjects with stool calprotectin value below 50ug/g from baseline to 12 months * Through analysis of metabonomics on biopsies, blood, urine and stools * Through analysis of blood genotyping * Through analysis of gut microbiota composition
次要结局
- Number of IBD patients requiring an escalation treatment to be in clinical remission at 12 months(Baseline vs Baseline + 12 months)
- Assess healthy intra-individual variability of gut microbial activity and dietary behavior in relation to disease development and management(Baseline)
- Assess phenotypic traits between IBD patients in clinical remission at 12 months and non-IBD subjects(Baseline vs Baseline + 12 months)