Biologic and Immunomodulator Withdrawal in Pediatric Crohn Disease With Deep Clinical Remission Using the Crohn Disease Exclusion Diet
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Sustained Relapse-free Remission
研究概览
简要总结
The primary objective of this study is to determine whether pediatric Crohn Disease (CD) patients in long-standing remission remain in remission longer after stopping medications if they follow the Crohn's Disease Exclusion Diet (CDED). The hypothesis is that subjects on the CDED will have longer time-to-relapse as opposed to those on an unrestricted diet.
详细描述
Crohn disease (CD) is an idiopathic, chronic, relapsing and remitting inflammatory condition of the gastrointestinal tract with a high risk for complications and need for surgical interventions, particularly in children. Immunomodulators and biologic therapies are effective at inducing and maintaining remission in pediatric CD, yet there is no proven strategy for reducing exposure to medications once sustained remission has been achieved. Diet has been proven to impact disease activity in CD and may allow for sustained drug-free remission. The primary objective of this study is to determine whether pediatric CD patients in long-standing remission remain in remission longer after stopping medications if they follow the Crohn's Disease Exclusion Diet (CDED). The hypothesis is that subjects on the CDED will have longer time-to-relapse as opposed to those on an unrestricted diet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of Crohn Disease using the Revised Porto criteria who will be withdrawing from biologic or immunomodulator monotherapy as part of clinical care.
- •Normal Growth Velocity, or Tanner 5
- •Steroid-free Remission (Pediatric Crohn Disease Activity Index Score <10 without the height component) for at least 12 months prior to enrollment
- •Colonoscopy during the preceding 3 months with complete mucosal healing or only few aphthous ulcerations located in one segment
- •Stool calprotectin <250µg/g during the preceding 3 months
- •Parental/guardian permission (informed consent) and, if appropriate, child assent.
排除标准
- •Discontinuation of biologic or immunomodulator therapy by the subject without the approval of the primary gastroenterologist.
- •Those subjects who in the judgment of the investigative team are unable to complete the study endpoints.
结局指标
主要结局
Sustained Relapse-free Remission
时间窗: At 52 weeks following enrollment
Remission defined by the Pediatric Crohn Disease Activity Index, C-reactive protein, and stool calprotectin
次要结局
- Time-to-relapse(Up to 104 weeks)
- Microbial Composition of Gastrointestinal Tract (Types and Quantities of Microorganisms)(52 weeks)