Comparative Effectiveness of Exclusive Enteral Nutrition and Infliximab in Chinese Children With Active Crohn's Disease
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- the number of patients who reach mucosal healing at the end of treatment in Exclusive enteral nutrition group
研究概览
简要总结
prospectively compared Exclusive Enteral Nutrition with Infliximab in the clinical outcomes, mucosal healing, nutrition improvements, adverse effects and gastrointestinal microbiota changes on Chinese Children With active Crohn's Disease
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pediatric active Crohn's disease ( CD) patients who were newly diagnosed at the Children's Hospital of Fudan University from October 2020 to Sep 2022，CD was diagnosed according to the Porto criteria and based on a combination of history, physical and laboratory examination, endoscopy with histology, and imaging of the small bowel (capsule endoscopy or magnetic resonance imaging or enhanced computerized tomography).
- •SES-CD>4 and PCDAI >10 at initial
- •For the patients whose fecal will be analyzed shouldn't take antibiotics or probiotics within the 1.5 months prior to the study and during the treatment.
- •healthy controls:
- •free medical history
- •had not taken antibiotics or probiotics within the 1.5 months prior to donate their fecal
排除标准
- •patients who had gene mutation or combined with other intestinal diseases such as tuberculosis or EB infection
- •for patients in the EEN group who could not finish the daily prescribed volume of formula for any reason; for the patients in the IFX group who could not finish the first 4 times IFX injection for any reason.
- •patients who were administered EEN, corticosteroids, immunosuppressive drugs, or biological agents prior to the study;
- •patients who could not attend consecutive follow-up sessions;
结局指标
主要结局
the number of patients who reach mucosal healing at the end of treatment in Exclusive enteral nutrition group
时间窗: at the end of 8 week of treatment.
the mucosal healing was defined as Simple Endoscopic Score for CD （SES-CD ）≤4 at the end of treatment . For the SES-CD, the intestine is divided into 5 anatomic segments under the endoscopic vision: rectum, left side of the colon segment, transverse colon, right side of the colon segment, and ileum. Items of interest include ulcer size, estimates of the ulcerated and affected surface, and the presence of luminal narrowing. The SES-CD score is calculated by combining scores of individual segments. Overall SES-CD scores are classified into 4 disease categories: none, 0 to 2; mild 2 to 4; moderate 5 to 15; and severe\>16.
the number of patients who reach mucosal healing at the end of treatment in Infliximab group
时间窗: at the end of 14 week of treatment.
the mucosal healing was defined as Simple Endoscopic Score for CD （SES-CD ）≤4 at the end of treatment . For the SES-CD, the intestine is divided into 5 anatomic segments under the endoscopic vision: rectum, left side of the colon segment, transverse colon, right side of the colon segment, and ileum. Items of interest include ulcer size, estimates of the ulcerated and affected surface, and the presence of luminal narrowing. The SES-CD score is calculated by combining scores of individual segments. Overall SES-CD scores are classified into 4 disease categories: none, 0 to 2; mild 2 to 4; moderate 5 to 15; and severe\>16.
次要结局
未报告次要终点
研究者
Ying HUANG
Director
Children's Hospital of Fudan University