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

Crohn Disease Clinical Trial

Official title:
Adaptation of the Mediterranean Diet Pattern to the Exclusion Diet for Crohn's Disease: Assessment of Efficacy and Tolerability in Pediatric and Adult Patients. Non-profit, Multicenter, Randomized, Controlled Study.

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06324513
Study type Interventional
Source Meyer Children's Hospital IRCCS
Contact Paolo Lionetti, MD
Phone 3398416059
Email paolo.lionetti@meyer.it
Status Recruiting
Phase N/A
Start date July 27, 2023
Completion date October 27, 2025
View Details
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