Exocrine Pancreatic Insufficiency's Prevalence in Active Crohn's Disease Treated by Biological Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Exocrine pancreatic insufficiency's prevalence
研究概览
简要总结
This study aims to assess the prevalence of exocrine pancreatic insufficiency (EPI) in a population of patients with active Crohn's disease. Studies already describe a prevalence rate around 18-66%. In this multicentric prospective study, we plan to compare EPI's prevalence at week 0 and week 14 of an induction phase of a biological therapy. The biological therapy will be initiate for an active Crohn's disease. Secondary outcomes will be: malnutrition's prevalence, and Crohn's disease activity level.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 18 years or more
- •Crohn's disease diagnosed for more than 3 months.
- •Active Crohn's disease : CDAI score > 150 + [CRP > 5 mg/L or faecal calprotectin > 250mcg/g or endoscopic lesion or MRI lesion]
- •Indication of a biological therapy (anti-TNFα, vedolizumab ou ustekinumab).
排除标准
- •Crohn's disease that doesn't fit the previous criteria
- •Extended resection of small intestine (>40cm)
- •Chronic pancreatitis diagnosed before inclusion
- •Contraindication to biological therapy (anti-TNFα, vedolizumab ou ustekinumab)
- •Pancreatic enzyme replacement therapy
- •Pregnant or breastfeeding woman
- •Patient under the protection of a conservator
研究组 & 干预措施
Crohn's Disease
干预措施: Search for exocrine pancreatic insufficiency at week 0 and 12 (Biological)
结局指标
主要结局
Exocrine pancreatic insufficiency's prevalence
时间窗: week 14
Exocrine pancreatic insufficiency will be defined as the association of : fecal elastase \<200 mcg/g and steatorrhea (\>7g of fecal fat per day) or an fat absorption rate \< 95%
次要结局
未报告次要终点