Dietary intervention for children with Juvenile Idiopathic Arthritis

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

This study is testing if a special diet without certain ingredients can help children with Juvenile Idiopathic Arthritis feel better over four weeks.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 6 Years to 18 Years
• Sex: All
• Sponsor: Meyer Children's Hospital IRCCS (Academic / other)
• Drugs / interventions: prednisone
• Locations: 1 site (Florence)
• Trial ID: NCT06874608 on ClinicalTrials.gov

What this trial studies

This pilot project evaluates the effectiveness of a complete, polymeric, fiber, lactose, and gluten-free diet in children aged 6 to 18 with Juvenile Idiopathic Arthritis (JIA). The study aims to determine if a 4-week exclusion diet can lead to improvements in disease activity, similar to findings in other inflammatory conditions. Participants will be assessed for their response to the diet using the Juvenile Arthritis Disease Activity Score (JADAS10).

Who should consider this trial

Good fit: Ideal candidates are children aged 6 to 18 with a confirmed diagnosis of mild to moderate JIA who have not responded adequately to current pharmacological therapies.

Not a fit: Patients requiring systemic immunosuppressive therapy for active uveitis or those on systemic corticosteroids may not benefit from this dietary intervention.

Why it matters

Potential benefit: If successful, this dietary approach could provide a non-pharmacological treatment option for managing symptoms of JIA in children.

How similar studies have performed: Previous studies in other inflammatory diseases have shown promising results with similar dietary interventions, suggesting potential for success in this context.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Florence

• AOU Meyer IRCCS — Florence, Italy (Recruiting)

Study contacts

• Study coordinator: Polo Lionetti, MD, PhD, Ordinary Professor

Conditions Juvenile Idiopathic Arthritis; JIA; CDED; Dietary therapy