Evaluation of the Efficacy and Tolerability of the Mediterranean Diet Pattern in the Exclusion Diet for Patients With Crohn's Disease. - Trial NCT06324513

Timeline & Enrollment

Primary Outcome

Clinical response to the first phase of diet,Clinical remission rate,Adherence rate to the Med-CDED diet and comparison to the original CDED both in pediatric and adult cohort,Clinical remission rate in adult patients at the end of phase I of diet

Summary

The proposed study aims to assess the efficacy and tolerability of adapting the CDED to the
 Mediterranean diet pattern, without compromising its key principles, namely the exclusion of
 ultra-processed foods with potential pro-inflammatory effects on the intestines. The decision
 to modify the CDED according to the characteristics of the Mediterranean diet pattern and to
 evaluate the potential of this modified version of the exclusion diet for Crohn's disease in
 terms of efficacy and tolerability are the main objectives of this study.
 
 These objectives are driven not only by scientific evidence regarding the anti-inflammatory
 potential and protective role against chronic-degenerative diseases demonstrated by the
 Mediterranean diet but also to allow for greater adherence to Italian dietary traditions and
 improve compliance with the dietary regimen.
 
 Furthermore, to date, there are no comprehensive multi-omic investigations integrating
 dietary data with microbiome, metabolome, and transcriptome profiles that can demonstrate the
 effect of the CDED at omic levels. A very recent study on pediatric patients shows
 interesting results regarding differential profiles of fecal metabolites after administration
 of CDE or NEE in different weeks of therapy.

ICD-10 Classifications