Diet as Adjuvant Therapeutics in the Era of Biologics in Pediatric-onset Crohn's Disease.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Level of calprotectin
研究概览
简要总结
Cded in remission patients with high calprotectin
详细描述
Due to the success of diet in achieving remission in mild-moderate forms of the disease, and an increasing number of patients with loss of response to available drugs despite increasing dose and pathophysiology of the disease, the aim of the present study is to evaluate whether there is response with the addition of diet therapy in patients with moderate/severe forms of CD receiving biologic therapy (infliximab or adalimumab) and presenting active 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
- None
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients under 18 years of age
- •With a diagnosis of CD
- •Who have completed remission induction with biologic therapy
- •Who are on maintenance biologic therapy
- •Present calprotectin values higher than the limit values established by the laboratory (higher than 250 ug/g).
排除标准
- •Children who are unable to receive enteral dietary intake
- •Comorbidities affecting nutritional status and/or bone metabolism, growth or pubertal development
- •Children already on special diets
研究组 & 干预措施
Diet
Patients will do biologic treatment according to international guidelines and will do Crohns Disease Exclusion Diet( modulen- phase one ant two CDED) for 12 weeks.They will be monitored periodically by interview and physical examination by physician and nutritionist, laboratory, fecal calprotectin.
干预措施: Crohn's disease exclusion diet (Dietary Supplement)
Control
Patients with normal treatment( biologic treatment indicated for CD)
结局指标
主要结局
Level of calprotectin
时间窗: week 12
To evaluate the change of the calprotectin value at 0 and 12 weeks in patients with or without the addition of dietary therapy.
Number of Participants with calprotectin less than 250 at week 12
时间窗: week 12
Number of participants who achieve normal fecal calprotectin after the diet
次要结局
- Adherence(12 weeks)
研究者
MARIA SOLEDAD ARCUCCI
principal investigator
Hospital Italiano de Buenos Aires