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

Official title

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

Overview

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.

Interventions

• Dietary supplement complete, polymeric formula, fiber, lactose and gluten free
  The dietary intervention attempts to induce remission in the first 4-week treatment without any change in the pharmaceutical therapy. In case of worsening or not reaching the outcomes, the patient will be defined as a failure and start rescue therapy with the standard of care.

Primary outcome measures

• Number of patients showing 20% improvement in juvenile arthritic disease activity score (JADAS) [Time frame: Baseline, 4 weeks, 8 weeks post-enrollment]

Secondary outcome measures (3)

• Number of patients showing a high score on the Modulence Adherence Rating Scale (MARS) [Time frame: Week 4, week 8, week 16, week 26 post-enrollment]
• Number of patients showing reduction of Reactive C Protein (RCP) after exclusion diet [Time frame: Baseline, 4 weeks, 8 weeks post-enrollment]
• Number of patients showing reduction of erythrocyte sedimentation rate (ESR) after exclusion diet [Time frame: Baseline, 4 weeks, 8 weeks post-enrollment]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

Italy · 1 center

• AOU Meyer IRCCS — Florence

Identifiers

NCT: NCT06874608 · JIA-ED

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗