Effect of Exclusive Enteral Nutrition on Disease Process, Nutritional Status and Intestinal Microbiota for Chinese Children With Crohn's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- 5-item gut microbiota measure
研究概览
简要总结
Inflammatory bowel diseases (IBD) are chronic inflammatory diseases. It is believed that the inflammation results from sustained abnormal immune response towards altered or pathogenic microbiota in genetically susceptible hosts. Malnutrition is common in IBD, especially in pediatric Crohn's disease(CD). Exclusive enteral nutrion(EEN) has been shown to improve nutritional status and inflammatory markers in pediatric CD. But there is limited data about the effect of EEN on Chinese children with CD. In this study, investigators focused on disease process,nutritional status and gut microbiome of Chinese children with newly-diagnosed CD after EEN treatment.
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
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pediatric CD patients who were newly diagnosed and being treated with EEN at the Children's Hospital of Fudan University
排除标准
- •(1) patients who were administered corticosteroids, immunosuppressive drugs, or biological agents prior to the study; (2) patients who could not finish the daily prescribed volume of formula for any reason; (3) patients who could not attend consecutive follow-up sessions; (4) patients who had received antibiotics or probiotics within 1.5 months prior to the study; and (5) patients who had been given corticosteroids, immunosuppressive drugs, biological agents, antibiotics, or probiotics during the EEN process.
结局指标
主要结局
5-item gut microbiota measure
时间窗: 0, 2, 6, 8, 12 weeks post-EEN
the change of gut microbiota during EEN and after the end of EEN
2-item Simple Endoscopic Score for CD (SES-CD)
时间窗: 0, 8, weeks post-EEN
According to the SES-CD, at the end of EEN, the patients whose SES-CD scores were ≤4 were classified into the remission group (CD-RE), other patients whose SES-CD scores were \>4 were classified into the non-remission group (CD-NRE)
次要结局
- 5-item Fecal Calprotectin(0, 2, 6, 8, 12 weeks post-EEN)
- 2-item Insulin-like growth factor-1(0, 8 weeks post-EEN)
- 2-item Calcium, vitamin(0, 8 weeks post-EEN)
- 5-item height measure(0, 2, 6, 8, 12 weeks post-EEN)
- 5-item weighted Paediatric Crohn's disease activity index measure(wPCDAI)(0, 2, 6, 8, 12 weeks post-EEN)
- 2-item 25-hydroxyvitamin D3 measure (25-OH VITD3)(0,8 weeks post-EEN)
- 5-item weight measure(0, 2, 6, 8, 12 weeks post-EEN)
研究者
Ying HUANG
The director of gastroenterology of Children's Hospital of Fudan University
Children's Hospital of Fudan University