The Effect of the Exclusive Enteral Nutrition Combined With Azathioprine in Maintaining Remission of Patients With Crohn's Diseases After Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- the 1 year postoperative anastomotic recurrence
研究概览
简要总结
for some patients with Crohn's diseases undergoing surgery，whether exclusive enteral nutrition(EEN) could delay the disease relapse needs exploration.The trial will study whether the efficacy of postoperative EEN could help keeping remission.
详细描述
For patients with Crohn's disease(CD), whether exclusive enteral nutrition(EEN) following bowel resection and anastomosis could delay the disease recurrence remains unkown. In this study， CD patients after surgery will be divided into two groups: one group is treated with 3 months' EEN and then turn to normal diet after 3 months; the other group is given with normal diet all through. All patients will be adminstrated with oral azathioprine after surgery. Then, the rates of 1 year postoperative endoscopic recurrence will be compared between groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- 否
入选标准
- •CD patients who undergoing bowel resection with anastomosis
排除标准
- •patients who had administered with immunomodulators or biological agents patients who were created stoma
研究组 & 干预措施
3 months exclusive enteral nutrition plus azathioprine
patients underwent surgery in this arm will given 3 months exclusive enteral nutrition,and free diet after 3 months. All patients will be adminsrated with oral azathioprine to preventing disease recurrence.
干预措施: postoperative 3-month exclusive enteral nutrition (Dietary Supplement)
3 months exclusive enteral nutrition plus azathioprine
patients underwent surgery in this arm will given 3 months exclusive enteral nutrition,and free diet after 3 months. All patients will be adminsrated with oral azathioprine to preventing disease recurrence.
干预措施: azathioprine (Drug)
normal diet plus azathioprine
patients underwent surgery in this arm will given free diet all through. All patients will be adminsrated with oral azathioprine to preventing disease recurrence.
干预措施: azathioprine (Drug)
normal diet plus azathioprine
patients underwent surgery in this arm will given free diet all through. All patients will be adminsrated with oral azathioprine to preventing disease recurrence.
干预措施: normal diet (Other)
结局指标
主要结局
the 1 year postoperative anastomotic recurrence
时间窗: 1 year
the 1 year postoperative anastomotic recurrence
次要结局
未报告次要终点
研究者
Zhu Weiming
Director, Head of General Surgery, Principal Investigator, Clinical Professor
Jinling Hospital, China