Actively Recruiting
Evaluation of the Efficacy and Tolerability of an Exclusion Diet in Patients With Juvenile Idiopathic Arthritis
Led by Meyer Children's Hospital IRCCS · Updated on 2025-03-13
20
Participants Needed
1
Research Sites
48 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 (JIA) in the enthesitis-related arthritis or oligoarticular forms according to ILAR 2001 criteria
- Age between 6 and 18 years (not yet 18)
- Mild to moderate active disease assessed by Juvenile Arthritis Disease Activity Score (JADAS10)
- For study groups 2 and 3: failure of pharmacological therapy after 3 months, defined as less than 20% improvement in JADAS10 or a 20% increase if disease inactive on therapy
- 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 >7 days) or intra-articular corticosteroids within 3 months prior to enrollment
- Fecal calprotectin values >250 mcg/g at screening
- Use of antibiotics within 1 month prior to enrollment
AI-Screening
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Trial Site Locations
Total: 1 location
1
AOU Meyer IRCCS
Florence, Italy, 50139
Actively Recruiting
Research Team
P
Polo Lionetti, MD, PhD, Ordinary Professor
CONTACT
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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