Dietary intervention for children with Juvenile Idiopathic Arthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot project evaluates the effectiveness of a complete, polymeric, fiber, lactose, and gluten-free diet in children aged 6 to 18 with Juvenile Idiopathic Arthritis (JIA). The study aims to determine if a 4-week exclusion diet can lead to improvements in disease activity, similar to findings in other inflammatory conditions. Participants will be assessed for their response to the diet using the Juvenile Arthritis Disease Activity Score (JADAS10).

Why it matters

Who can join: the full rules

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.

Where it's running

• AOU Meyer IRCCS
  Florence, Italy Recruiting

Study contacts

• Study coordinator: Polo Lionetti, MD, PhD, Ordinary Professor
• Email: paolo.lionetti@unifi.it
• Phone: +39 3398416059

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Parents' pain catastrophizing in children with juvenile idiopathic arthritis

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.