Status:
RECRUITING
Evaluation of the Efficacy and Tolerability of an Exclusion Diet in Patients With Juvenile Idiopathic Arthritis
Lead Sponsor:
Meyer Children's Hospital IRCCS
Conditions:
Juvenile Idiopathic Arthritis (JIA)
Eligibility:
All Genders
6-18 years
Phase:
NA
Brief Summary
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. T...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 15 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06874608
Start Date
December 12 2024
End Date
November 15 2025
Last Update
March 13 2025
Active Locations (1)
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1
AOU Meyer IRCCS
Florence, Italy, 50139