Actively Recruiting
Evaluation of the Efficacy and Tolerability of an Exclusion Diet in Patients With Juvenile Idiopathic Arthritis: Interventional, Exploratory, Randomized Controlled Open-label Add-on Study
Led by Meyer Children's Hospital IRCCS · Updated on 2025-03-13
20
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of an exclusion diet on patients aged 6 to 18 with juvenile idiopathic arthritis (JIA), focusing on specific forms such as enthesitis-related arthritis and oligoarticular types. The study is exploratory and randomized, designed to evaluate the diet’s impact within a 4-week period based on evidence from a similar dietary approach used in Crohn's disease. The goal is to assess improvements in disease activity and tolerability of this dietary intervention. Participants will be randomly assigned to one of two groups: one receiving standard care with a free diet, and the other following the Crohn Disease Exclusion Diet (CDED) combined with partial enteral nutrition. The dietary intervention aims to induce remission in the first 4 weeks without changing existing drug therapies initially. If patients do not improve or worsen, they will receive rescue standard care treatment. The study is open-label and includes an add-on dietary approach. Throughout the study, participants will be monitored at baseline, 4 weeks, and 8 weeks for improvements in juvenile arthritis symptoms using the Juvenile Arthritis Disease Activity Score (JADAS). Additional assessments include adherence to the diet, inflammation markers like Reactive C Protein and erythrocyte sedimentation rate, and safety monitoring. The study spans several weeks, with ongoing evaluation of responses to the diet and any necessary adjustments in treatment.
CONDITIONS
Brief Title
Evaluation of the Efficacy and Tolerability of an Exclusion Diet in Patients With Juvenile Idiopathic Arthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of juvenile idiopathic arthritis (enthesitis-related arthritis or oligoarticular forms) according to ILAR 2001 criteria
- Age between 6 and 18 years (not yet 18)
- Active mild to moderate disease assessed by Juvenile Arthritis Disease Activity Score (JADAS10)
- For some groups: failure of pharmacological therapy with less than 20% improvement after 3 months of DMARD or biologic treatment
- Signed informed consent
You will not qualify if you...
- Need for systemic immunosuppressive therapy for active uveitis
- Use of systemic corticosteroids (prednisone equivalent >0.5 mg/kg for over 7 days) or intra-articular corticosteroids within 3 months before enrollment
- Fecal calprotectin values greater than 250 mcg/g at screening
- Use of antibiotics in the month before enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants follow an exclusion diet combined with partial enteral nutrition or receive standard of care therapy and free diet without changes in their pharmaceutical treatment during the first 4 weeks.
Visits at baseline, Week 4, and Week 8
Duration - Up to 22 weeks after treatment
Participants are monitored for adherence to the diet and disease activity up to 26 weeks post-enrollment.
Visits at Week 16 and Week 26
Trial Site Locations
Total: 1 location
1
AOU Meyer IRCCS
Florence, Italy, 50139
Actively Recruiting
Research Team
P
Polo Lionetti, MD, PhD, Ordinary Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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