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

NCT ID: NCT06874608

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-12
• Study Completion Date: 2025-11-15

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.

Conditions

Juvenile Idiopathic Arthritis (JIA)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standard of care

In this arm patients of newly diagnosis, or who failed synthetic or biologic therapy will be treated with standard of care therapy and free diet

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention arm

In this arm patients of newly diagnosis, or who failed synthetic or biologic therapy will be treated with the Crohn Disease Exclusion Diet (CDED) plus partial enteral nutrition

Group Type: EXPERIMENTAL

complete, polymeric formula, fiber, lactose and gluten free

Intervention Type: 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.

Interventions

complete, polymeric formula, fiber, lactose and gluten free

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meyer Children's Hospital IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Paolo Lionetti

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

AOU Meyer IRCCS

Florence, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Polo Lionetti, MD, PhD, Ordinary Professor

Role: CONTACT

paolo.lionetti@unifi.it

+39 3398416059

Facility Contacts

Paolo Lionetti, MD, PhD, Ordinary Professor

Role: primary

paolo.lionetti@unifi.it

+39 3398416059

Other Identifiers

JIA-ED

Identifier Type: -

Identifier Source: org_study_id