Semi-elemental Versus Polymeric Exclusive Enteral Nutrition in the Preoperative Optimization for Patients with Crohn's Disease: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 304
- 试验地点
- 1
- 主要终点
- The change of CRP/ALB level
研究概览
简要总结
Growing evidence has shown that exclusive enteral nutrition (EEN) plays an important role in the preoperative optimization for patients with Crohn's disease (CD). However, the efficacy and safety of different types of enteral feeds including semi-elemental and polymeric enteral nutrition on CD have not been investigated. The aim of this study was to compare the role of semi-elemental and polymeric enteral nutrition on CD.
详细描述
Growing evidence has shown that exclusive enteral nutrition (EEN) plays an important role in the preoperative optimization for patients with Crohn's disease (CD). However, the efficacy and safety of different types of enteral feeds including semi-elemental and polymeric enteral nutrition on CD have not been investigated. The aim of this study was to compare the role of semi-elemental and polymeric enteral nutrition on CD. The primary outcome: the reduction rate of CRP/ALB after exclusive enteral nutrition in Crohn's disease. The other outcomes: (1) the changes in Crohn's disease activity index; (2) the tolerance of enteral nutrition; (3) the changes in body mass index; (4) postoperative complications and the incidence of stoma; (5) the rate of surgery; (6) other adverse reactions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •elective bowel resection for Crohn's disease;
- •preoperative diagnosis of Crohn's disease;
- •age between 18 to 65 years old;
- •malnutrition;
- •the Crohn's disease activity index over 150;
- •nasal feeding.
排除标准
- •emergency surgery;
- •preoperative exclusive enteral nutrition before three months;
- •can not tolerate enteral nutrition;
- •less than 6 weeks of exclusive enteral nutrition;
- •preoperative corticosteroids within 3 months;
- •history of gastrointestinal surgery;
- •isolated colon disease;
- •metabolic disease (diabetes, hyperthyroidism).
研究组 & 干预措施
SED patient
SED patients who received semi-elemental exclusive enteral nutrition.
干预措施: peptison liquid (Dietary Supplement)
PD patient
PD patients who received polymeric exclusive enteral nutrition.
干预措施: Enteral nutritional suspension (Dietary Supplement)
结局指标
主要结局
The change of CRP/ALB level
时间窗: 6 weeks
The ratio of C-reactive protein to albumin level changed after exclusive enteral nutrition.
次要结局
- BMI(6 weeks)
- CDAI(6 weeks)
- postoperative complications(6 weeks)
- adverse reaction(6 weeks)
研究者
Wei Zhou
Clinical Professor
Sir Run Run Shaw Hospital