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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Number of patients showing 20% improvement in juvenile arthritic disease activity score (JADAS)
Study Overview
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. 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Standard of care
In this arm patients of newly diagnosis, or who failed synthetic or biologic therapy will be treated with standard of care therapy and free diet
Intervention arm
In this arm patients of newly diagnosis, or who failed synthetic or biologic therapy will be treated with the Crohn Disease Exclusion Diet (CDED) plus partial enteral nutrition
Intervention: complete, polymeric formula, fiber, lactose and gluten free (Dietary Supplement)
Outcomes
Primary Outcomes
Number of patients showing 20% improvement in juvenile arthritic disease activity score (JADAS)
Time Frame: Baseline, 4 weeks, 8 weeks post-enrollment
Secondary Outcomes
- Number of patients showing reduction of Reactive C Protein (RCP) after exclusion diet(Baseline, 4 weeks, 8 weeks post-enrollment)
- Number of patients showing a high score on the Modulence Adherence Rating Scale (MARS)(Week 4, week 8, week 16, week 26 post-enrollment)
- Number of patients showing reduction of erythrocyte sedimentation rate (ESR) after exclusion diet(Baseline, 4 weeks, 8 weeks post-enrollment)
Investigators
Paolo Lionetti
Principal Investigator
Meyer Children's Hospital IRCCS