Ulcerative Colitis Endoscopic Index of Severity and Fecal Calprotectin to Predict the Reaction to Corticosteroids of Acute Severe Ulcerative Colitis: A Prospective Observational Study
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- C-reactive protein (CRP) at day 3
研究概览
简要总结
For acute severe colitis (ASC) patients, corticosteroids (CS) was recommended as the first-line treatment in the guideline, but patients have a great risk of requiring colectomy or turning to second-line treatment. This study aim to verify the effectiveness of ulcerative colitis endoscopic index of severity(UCEIS) in predicting the reaction to corticosteroids, and explores the possibility that noninvasive marker fecal calprotectin (FC) could act as an alternative to UCEIS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients with a confirmed diagnosis of ASC according to Truelove and Witt's criteria;
- •Patients were generally able to tolerate the flexible colonoscopy before start of CS treatment;
排除标准
- •Patients with incomplete colonoscopy, inadequate fecal sample;
- •Patients with indeterminate diagnosis of ASC (colorectal cancer, Crohn's disease) according to colonoscopy;
- •Patients with infectious colitis, Clostridium difficile and CMV infection, primary immunodeficiency, recent history of immunosuppressant within 3 months.
- •Patients with bowel resection, intestinal anastomotic, and ileum enterostomy.
研究组 & 干预措施
CS
Intravenous steroids were started with methylprednisolone 60 mg/d or hydrocortisone 400 mg/d for 3 days.
干预措施: corticosteroids (Drug)
结局指标
主要结局
C-reactive protein (CRP) at day 3
时间窗: 3 days
The response to intravenous steroid therapy was judged at day 3 according to Oxford criteria.
stool frequency at day 3
时间窗: 3 days
The response to intravenous steroid therapy was judged at day 3 according to Oxford criteria.
次要结局
- ulcerative colitis endoscopic index of severity (UCEIS) before treatment(3 days)
- Fecal Calprotectin before treatment(3 days)
研究者
Jianfeng Gong
Associate professor
Jinling Hospital, China