Multimodal Approach in IBD Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- prevalence of vitamin D deficiency
研究概览
简要总结
The investigators intend to assess the role of several biomarkers in the prediction of relapse in IBD. Clinical, laboratory and endoscopic data will be gathered and a predictive score will be derived in order to assess the relapse risk at 1 year.
详细描述
Patients with a confirmed diagnosis of IBD will be prospectively assessed on a yearly basis in order to assess relapse risk factors.
Disease activity will be assessed using the Mayo score for UC patients and CDAI for Crohn's disease and endoscopic activity will be assessed using the Mayo endoscopic subscore for UC patients and the Simple Endoscopic Score for Crohn's Disease for CD patients.
Serum and fecal biomarkers will be obtainted at each study visit (C-reactive protein, fecal calprotectin).
Data about current and past medication for IBD will also be gathered.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ulcerative colitis or Crohn's disease
- •age over 18
- •clinical remission
- •signed informed consent
排除标准
- •pregnant women
- •refusal to sign informed consent
结局指标
主要结局
prevalence of vitamin D deficiency
时间窗: 1 year
to assess vitamin D deficiency and osteopenia among IBD patients
Clinical relapse
时间窗: 1 year
clinical relapse as assessed by conventional scores for activity in IBD - Mayo or CDAI
Prevalence of NAFLD
时间窗: 1 year
to assess the prevalence of nonalcoholic liver disease in IBD patients
次要结局
未报告次要终点
研究者
dr. Theodor Alexandru Voiosu
Gastroenterology resident, Teaching Assistant
Clinical Hospital Colentina