Evaluation of the Efficacy and Tolerability of an Exclusion Diet in Patients With Juvenile Idiopathic Arthritis

Last updated: March 12, 2025
Sponsor: Meyer Children's Hospital IRCCS
Overall Status: Active - Recruiting

Phase

N/A

Condition

Joint Injuries

Treatment

complete, polymeric formula, fiber, lactose and gluten free

Clinical Study ID

NCT06874608
JIA-ED
  • Ages 6-18
  • All Genders

Study 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

Inclusion Criteria:

  • Confirmed diagnosis of juvenile idiopathic arthritis (JIA) in the forms ofenthesitis-related arthritis and oligoarticular forms according to the ILAR 2001criteria (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., AmericanCollege Rheumatology, 2021);

  • For study groups 2 and 3: failure of ongoing pharmacological therapy at the time ofscreening, defined as a failure to achieve at least a 20% reduction in JADAS10values after 3 months of initiating DMARD therapy or biologic medication, or if thedisease is inactive on such therapy, a 20% increase in those values;

  • Signed informed consent.

Exclusion

Exclusion Criteria:

  • Patients requiring systemic immunosuppressive therapy for active uveitis;

  • Patients undergoing therapy with systemic corticosteroids (defined as prednisoneequivalent >0.5 mg/kg for >7 days) or intra-articular corticosteroids in the 3months 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.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: complete, polymeric formula, fiber, lactose and gluten free
Phase:
Study Start date:
December 12, 2024
Estimated Completion Date:
November 15, 2025

Connect with a study center

  • AOU Meyer IRCCS

    Florence, 50139
    Italy

    Active - Recruiting

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