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

NCT06874608 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-03-13

No results posted yet for this 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.

Conditions

  • Juvenile Idiopathic Arthritis (JIA)

Interventions

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.

Sponsors & Collaborators

  • Meyer Children's Hospital IRCCS

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-12
Primary Completion
2025-05-15
Completion
2025-11-15

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06874608 on ClinicalTrials.gov