Phase
Condition
Joint Injuries
Treatment
complete, polymeric formula, fiber, lactose and gluten free
Clinical Study ID
Ages 6-18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Confirmed diagnosis of juvenile idiopathic arthritis (JIA) in the forms ofenthesitis-related arthritis and oligoarticular forms according to the ILAR 2001criteria (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., AmericanCollege Rheumatology, 2021);
For study groups 2 and 3: failure of ongoing pharmacological therapy at the time ofscreening, defined as a failure to achieve at least a 20% reduction in JADAS10values after 3 months of initiating DMARD therapy or biologic medication, or if thedisease is inactive on such therapy, a 20% increase in those values;
Signed informed consent.
Exclusion
Exclusion Criteria:
Patients requiring systemic immunosuppressive therapy for active uveitis;
Patients undergoing therapy with systemic corticosteroids (defined as prednisoneequivalent >0.5 mg/kg for >7 days) or intra-articular corticosteroids in the 3months 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.
Study Design
Connect with a study center
AOU Meyer IRCCS
Florence, 50139
ItalyActive - Recruiting
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