Evaluation of the Efficacy and Tolerability of an Exclusion Diet in Patients With Juvenile Idiopathic Arthritis: Interventional, Exploratory Single-center, Randomized, Controlled, Open-label, add-on Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of patients showing 20% improvement in juvenile arthritic disease activity score (JADAS)
研究概览
简要总结
The JIA-ED study is a pilot project. Based on experience in another inflammatory disease, a 4-week period was extrapolated as sufficient to assess the effectiveness of the experimental intervention. This observation is supported by literature data showing that, halfway through phase I of the CDED (Crohn Diseasse Exclusion Diet), it is already possible to identify a subset of patients with Crohn's disease who are responsive to the dietary treatment and who also have a higher likelihood of achieving clinical remission by the end of the first phase of the diet itself.
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
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of juvenile idiopathic arthritis (JIA) in the forms of enthesitis-related arthritis and oligoarticular forms according to the ILAR 2001 criteria (https://medicalcriteria.com/web/reujia/);
- •Age between 6 and 18 years (not yet 18);
- •Active disease of mild to moderate severity, assessed through the Juvenile - Arthritis Disease Activity Score (JADAS10) tool (Trincianti C. et al., American College Rheumatology, 2021);
- •For study groups 2 and 3: failure of ongoing pharmacological therapy at the time of screening, defined as a failure to achieve at least a 20% reduction in JADAS10 values after 3 months of initiating DMARD therapy or biologic medication, or if the disease is inactive on such therapy, a 20% increase in those values;
- •Signed informed consent.
排除标准
- •Patients requiring systemic immunosuppressive therapy for active uveitis;
- •Patients undergoing therapy with systemic corticosteroids (defined as prednisone equivalent >0.5 mg/kg for >7 days) or intra-articular corticosteroids in the 3 months prior to enrollment;
- •Patients with fecal calprotectin values > 250 mcg/g at the time of screening;
- •Use of antibiotics in the month prior to enrollment.
研究组 & 干预措施
Standard of care
In this arm patients of newly diagnosis, or who failed synthetic or biologic therapy will be treated with standard of care therapy and free diet
Intervention arm
In this arm patients of newly diagnosis, or who failed synthetic or biologic therapy will be treated with the Crohn Disease Exclusion Diet (CDED) plus partial enteral nutrition
干预措施: complete, polymeric formula, fiber, lactose and gluten free (Dietary Supplement)
结局指标
主要结局
Number of patients showing 20% improvement in juvenile arthritic disease activity score (JADAS)
时间窗: Baseline, 4 weeks, 8 weeks post-enrollment
次要结局
- Number of patients showing reduction of Reactive C Protein (RCP) after exclusion diet(Baseline, 4 weeks, 8 weeks post-enrollment)
- Number of patients showing a high score on the Modulence Adherence Rating Scale (MARS)(Week 4, week 8, week 16, week 26 post-enrollment)
- Number of patients showing reduction of erythrocyte sedimentation rate (ESR) after exclusion diet(Baseline, 4 weeks, 8 weeks post-enrollment)
研究者
Paolo Lionetti
Principal Investigator
Meyer Children's Hospital IRCCS