Clinical trial NCT06874608: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Juvenile Idiopathic Arthritis (JIA)
Keywords: JIA
CDED
Dietary therapy
Lead sponsor: Meyer Children's Hospital IRCCS
Sponsor class: OTHER
First posted: 2025-03-13
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Number of patients showing 20% improvement in juvenile arthritic disease activity score (JADAS)
timeFrame: Baseline, 4 weeks, 8 weeks post-enrollment
Secondary outcomes:
measure: Number of patients showing a high score on the Modulence Adherence Rating Scale (MARS)
timeFrame: Week 4, week 8, week 16, week 26 post-enrollment
measure: Number of patients showing reduction of Reactive C Protein (RCP) after exclusion diet
timeFrame: Baseline, 4 weeks, 8 weeks post-enrollment
measure: Number of patients showing reduction of erythrocyte sedimentation rate (ESR) after exclusion diet
timeFrame: Baseline, 4 weeks, 8 weeks post-enrollment
Other outcomes:
measure: Percentage of patients with gut microbiota modifications
timeFrame: Baseline, week 4, week 8, week 16, week 26 post-enrollment
Locations:
city: Florence
country: Italy
facility: AOU Meyer IRCCS
Study officials:
References: