Juvenile Idiopathic Arthritis (JIA)
Conditions
Keywords
JIA, CDED, Dietary therapy
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.
Interventions
DIETARY_SUPPLEMENTcomplete, 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.
Sponsors
Meyer Children's Hospital IRCCS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients showing 20% improvement in juvenile arthritic disease activity score (JADAS) | Baseline, 4 weeks, 8 weeks post-enrollment |
Secondary
| Measure | Time frame |
|---|---|
| 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 Reactive C Protein (RCP) after exclusion diet | Baseline, 4 weeks, 8 weeks post-enrollment |
| Number of patients showing reduction of erythrocyte sedimentation rate (ESR) after exclusion diet | Baseline, 4 weeks, 8 weeks post-enrollment |
Other
| Measure | Time frame |
|---|---|
| Percentage of patients with gut microbiota modifications | Baseline, week 4, week 8, week 16, week 26 post-enrollment |
Countries
Italy
Contacts
Primary ContactPolo Lionetti, MD, PhD, Ordinary Professor
Outcome results
None listed