NCT06874608 Evaluation of the Efficacy and Tolerability of an Exclusion Diet in Patients With Juvenile Idiopathic Arthritis
| NCT ID | NCT06874608 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Meyer Children's Hospital IRCCS |
| Condition | Juvenile Idiopathic Arthritis (JIA) |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-12-12 |
| Primary Completion | 2025-05-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2024-12-12 with a primary completion date of 2025-05-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06874608 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 18 Years, studying Juvenile Idiopathic Arthritis (JIA). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06874608 currently recruiting?
Yes, NCT06874608 is actively recruiting participants. Contact the research team at paolo.lionetti@unifi.it for enrollment information.
Where is the NCT06874608 trial being conducted?
This trial is being conducted at Florence, Italy.
Who is sponsoring the NCT06874608 clinical trial?
NCT06874608 is sponsored by Meyer Children's Hospital IRCCS. The trial plans to enroll 20 participants.