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NCT Number: NCT06874608

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

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.

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Key information

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AOU Meyer IRCCS

Florence, 50139, Italy

Location status: Recruiting

Location contact

Paolo Lionetti, MD, PhD, Ordinary Professor

CONTACT

[email protected]

+39 3398416059

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

complete, polymeric formula, fiber, lactose and gluten free

Dietary Supplement

The dietary intervention attempts to induce remission in the first 4-week treatment without any change in the pharmaceutical therapy. In case of worsening or not reaching the outcomes, the patient will be defined as a failure and start rescue therapy with the standard of care.

Primary outcomes

  1. Number of patients showing 20% improvement in juvenile arthritic disease activity score (JADAS)

    Time frame: Baseline, 4 weeks, 8 weeks post-enrollment

Secondary outcomes

  1. Number of patients showing a high score on the Modulence Adherence Rating Scale (MARS)

    Time frame: Week 4, week 8, week 16, week 26 post-enrollment

  2. Number of patients showing reduction of Reactive C Protein (RCP) after exclusion diet

    Time frame: Baseline, 4 weeks, 8 weeks post-enrollment

  3. Number of patients showing reduction of erythrocyte sedimentation rate (ESR) after exclusion diet

    Time frame: Baseline, 4 weeks, 8 weeks post-enrollment

Other outcomes

  1. Percentage of patients with gut microbiota modifications

    Time frame: Baseline, week 4, week 8, week 16, week 26 post-enrollment

Study contacts

Contact information is provided by the study sponsor or research team.

Polo Lionetti, MD, PhD, Ordinary Professor

CONTACT

[email protected]

+39 3398416059

Sponsors and collaborators

Lead sponsor

Meyer Children's Hospital IRCCS

Other

Registry information

Official study title

Evaluation of the Efficacy and Tolerability of an Exclusion Diet in Patients With Juvenile Idiopathic Arthritis: Interventional, Exploratory Single-center, Randomized, Controlled, Open-label, add-on Study

Acronym: JIA-ED

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 13, 2025
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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