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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-18
SponsorMeyer Children's Hospital IRCCS

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • complete, polymeric formula, fiber, lactose and gluten free

Treatment groups

20 Participants
are divided into 2 treatment groups