Effectiveness and Pathogenesis of Specific Dietary Pattern in Maintaining Remission Among Crohn's Disease(CD) Patients Following Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Quality of Life(IBDQ)
研究概览
简要总结
Over the past 10 years, there are a large number of dietary treatments related to the CD, such as specific carbohydrate diet, low Fermentable Oligo-, Di-, Mono-saccharides And Polyols (FODMAP) diet, and allergen-free foods. But there is no consistent conclusion or convincing evidence about the effectiveness. Through the long-term clinical experience observation, we find most of the CD patients can get stable remission by removing refined food and intolerance food.This project aims at developing a new dietary therapy suitable for Chinese patients.
详细描述
The dietary therapy is based on the nutrient composition of exclusive enteral nutrition and is more in line with Chinese patients' dietary habits and economic conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnose CD according to endoscopy, histology and imaging;
- •Bowel resection for CD
- •Oral nutritional preparations or food can be given after surgery
排除标准
- •Plan operation within 5 weeks after surgery;
- •Presence of an ileostomy or colostomy
- •Complete bowel obstruction or fibrous stricture
- •Pregnancy or breastfeeding;
- •Plan to use biological agents within 5 weeks after surgery;
- •Plan to use corticosteroids or prednisone greater than 20 mg per day or equivalent doses of drugs to maintain remission within 5 weeks after surgery;
- •Plan to use probiotics or prebiotics for more than 1 week after surgery;
- •Antibiotics are used for more than 2 weeks after surgery;
- •Hypersensitivity to known components of enteral nutrition;
- •BMI less than 14 or greater than 28 kg/m2;
- •Celiac disease;
- •Complicated with other autoimmune diseases such as diabetes or rheumatic disease, autoimmune liver disease, psoriasis;
- •Mental illness;
- •Malignant tumors
- •Those who are not suitable for body composition analysis (such as pacemakers and metal objects in the body)
- •Participating in other clinical trials
- •The researcher believes that others are not suitable to participate in this study.
研究组 & 干预措施
Exclusive Enteral Nutrition(EEN)
Subjects required exclusive enteral nutrition for one month
干预措施: EEN (Other)
Specific Diet+ Partial Enteral Nutrition
Subjects received partial enteral nutrition with remaining energy and nutrients obtained through diet for one month
干预措施: dietary pattern (Other)
结局指标
主要结局
Quality of Life(IBDQ)
时间窗: The two groups of patients were scored at first week and sixth week after surgery.
IBDQ: Inflammatory Bowel Disease Questionnaire.The IBDQ evaluates the quality of life of patients from four aspects: intestinal symptoms, systemic symptoms, emotional function and social function. There are 32 questions in the questionnaire, with a total score of 32 to 224 points. The higher the score, the higher the quality of life of the patient.
次要结局
- nutritional status of the patient(The two groups were evaluated at first week and sixth week after surgery.)
- Disease-related evaluation indicators(The two groups were evaluated at first week and sixth week after surgery.)