Evaluation of the Efficacy and Tolerability of an Exclusion Diet in Patients With Juvenile Idiopathic Arthritis

Официальное название

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

Обзор

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.

Вмешательства

• Пищевая добавка complete, polymeric formula, fiber, lactose and gluten free
  The dietary intervention attempts to induce remission in the first 4-week treatment without any change in the pharmaceutical therapy. In case of worsening or not reaching the outcomes, the patient will be defined as a failure and start rescue therapy with the standard of care.

Первичные конечные точки

• Number of patients showing 20% improvement in juvenile arthritic disease activity score (JADAS) [Срок оценки: Baseline, 4 weeks, 8 weeks post-enrollment]

Вторичные конечные точки (3)

• Number of patients showing a high score on the Modulence Adherence Rating Scale (MARS) [Срок оценки: Week 4, week 8, week 16, week 26 post-enrollment]
• Number of patients showing reduction of Reactive C Protein (RCP) after exclusion diet [Срок оценки: Baseline, 4 weeks, 8 weeks post-enrollment]
• Number of patients showing reduction of erythrocyte sedimentation rate (ESR) after exclusion diet [Срок оценки: Baseline, 4 weeks, 8 weeks post-enrollment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Италия · 1 центр

• AOU Meyer IRCCS — Florence

Идентификаторы

NCT: NCT06874608 · JIA-ED

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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