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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
20
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.
AOU Meyer IRCCS
Florence, Italy
RECRUITINGNumber of patients showing 20% improvement in juvenile arthritic disease activity score (JADAS)
Time frame: Baseline, 4 weeks, 8 weeks post-enrollment
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
Number of patients showing reduction of Reactive C Protein (RCP) after exclusion diet
Time frame: Baseline, 4 weeks, 8 weeks post-enrollment
Number of patients showing reduction of erythrocyte sedimentation rate (ESR) after exclusion diet
Time frame: Baseline, 4 weeks, 8 weeks post-enrollment
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