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.
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;
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.
Parallel
complete, polymeric formula, fiber, lactose and gluten free
Dietary supplementThe 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.
Number of patients showing 20% improvement in juvenile arthritic disease activity score (JADAS)
Number of patients showing a high score on the Modulence Adherence Rating Scale (MARS)
Number of patients showing reduction of Reactive C Protein (RCP) after exclusion diet
Number of patients showing reduction of erythrocyte sedimentation rate (ESR) after exclusion diet
Percentage of patients with gut microbiota modifications
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