Evaluation of the Efficacy and Tolerability of an Exclusion Diet in Patients With Juvenile Idiopathic Arthritis (JIA-ED)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Juvenile Idiopathic Arthritis (JIA)
• Intervention / Treatment: Dietary supplement: complete, polymeric formula, fiber, lactose and gluten free

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

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

Study Locations

• Italy
  • Florence, Italy, 50139
    • Recruiting
    • AOU Meyer IRCCS
    • Contact: Paolo Lionetti, MD, PhD, Ordinary Professor; Phone Number: +39 3398416059; Email: paolo.lionetti@unifi.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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
Experimental: 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	Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients showing 20% improvement in juvenile arthritic disease activity score (JADAS)	Baseline, 4 weeks, 8 weeks post-enrollment

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of patients showing a high score on the Modulence Adherence Rating Scale (MARS)	Week 4, week 8, week 16, week 26 post-enrollment
Number of patients showing reduction of Reactive C Protein (RCP) after exclusion diet	Baseline, 4 weeks, 8 weeks post-enrollment
Number of patients showing reduction of erythrocyte sedimentation rate (ESR) after exclusion diet	Baseline, 4 weeks, 8 weeks post-enrollment

Other Outcome Measures

Outcome Measure	Time Frame
Percentage of patients with gut microbiota modifications	Baseline, week 4, week 8, week 16, week 26 post-enrollment

Collaborators and Investigators

• Sponsor: Meyer Children's Hospital IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2024
• Primary Completion (Estimated): May 15, 2025
• Study Completion (Estimated): November 15, 2025

Study Registration Dates

• First Submitted: February 25, 2025
• First Submitted That Met QC Criteria: March 12, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: JIA; CDED; Dietary therapy
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Arthritis; Arthritis, Juvenile
• Other Study ID Numbers: JIA-ED

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No