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

NCT06874608 | Recruiting

• 1 other identifier: JIA-ED
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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)

Keywords

JIA; CDED; Dietary therapy

Outcome Measures

Primary Outcomes (1)

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

  Baseline, 4 weeks, 8 weeks post-enrollment

Secondary Outcomes (3)

• 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 Outcomes (1)

• Percentage of patients with gut microbiota modifications

  Baseline, week 4, week 8, week 16, week 26 post-enrollment

Study Arms (2)

Standard of care

NO INTERVENTION

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

Intervention arm

EXPERIMENTAL

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

Interventions

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.

Intervention arm

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Meyer Children's Hospital IRCCS: lead

Study Sites (1)

AOU Meyer IRCCS

Florence, 50139, Italy

RECRUITING

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

Dietary Fiber; Lactose; Diet, Gluten-Free

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dietary Carbohydrates; Carbohydrates; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Disaccharides; Oligosaccharides; Polysaccharides; Sugars; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena

Central Study Contacts

Polo Lionetti, MD, PhD, Ordinary Professor

CONTACT

+39 3398416059; paolo.lionetti@unifi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 13, 2025
• Study Start: December 12, 2024
• Primary Completion: May 15, 2025
• Study Completion: November 15, 2025
• Last Updated: March 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)