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NCT06324513Recruiting

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

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.
Meyer Children's Hospital IRCCSClinicalTrials.govdietary supplement
Study focus
Disease/Condition
Crohn Disease
Drug/Device/Intervention
Mediterranean Crohn's Disease Exclusion Diet (Med-CDED)
Study type
Interventional
Intervention type
dietary supplement
Sponsor & location
Primary sponsor
Meyer Children's Hospital IRCCS
Location
Firenze,Palermo,Roma, Italy
Timeline & enrollment
Phase
N/A
Start date
Jul 27, 2023
End date
Oct 27, 2025
Enrollment
120 participants
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
Crohn disease, unspecifiedOther Crohn diseaseCrohn disease of large intestineCrohn disease of small intestineCrohn disease [regional enteritis]
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06324513
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06324513 through Pure Global AI's free database. This phase not specified trial is sponsored by Meyer Children's Hospital IRCCS and is currently Recruiting. The study focuses on Crohn Disease. Target enrollment is 120 participants.

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