NCT06353633Unknown不适用
The Effect of Exclusion Diet for Crohn's Disease Plus Enteral Nutrition on Children and Adolescents With Crohn's Disease
National Nutrition and Food Technology Institute0 个研究点目标入组 44 人开始时间: 2024年4月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 44
- 主要终点
- CRP
研究概览
简要总结
In this study, children and adolescents with active Crohn's disease are placed in two intervention groups, the first group receives only an exclusion diet and the second group receives an exclusion diet plus formula.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children aged 4 to 18 years with active Crohn's disease
- •Pediatric Crohn's Disease Activity Index (PCDAI) ≥10 and ≤40
排除标准
- •Patients who receiving concurrent remission-inducing drugs such as steroids, 5-ASA, methotrexate, or antibiotics, as well as patients receiving induction doses of a biologic
结局指标
主要结局
CRP
时间窗: 8 weeks
c-reactive protein
ESR
时间窗: 8 weeks
erythrocyte sedimentation rate
FC
时间窗: 8 weeks
fecal calprotectin
PCDAI
时间窗: 8 weeks
pediatric chron disease activity index
Alb
时间窗: 8 weeks
serum albumin
次要结局
- weight(8 weeks)
- Arm Circumferance(8 weeks)
- BMI(8 weeks)
- Height(8 weeks)
研究者
Dr Azita Hekmatdoost
Principal Investigator
National Nutrition and Food Technology Institute
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