NCT06324513

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Meyer Children's Hospital IRCCS · Academic / Other
• Sex: All
• Age: 4 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Crohn Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Mediterranean Crohn's Disease Exclusion Diet (Med-CDED)	The Mediterranean Crohn's Disease Exclusion Diet (Med-CDED) is the exclusion diet (CDED) adapted to the Mediterranean diet pattern. The Med-CDED consists of 2 phases in dietary therapy and a maintenance phase: the first phase lasting 8 weeks, the second phase lasting 16 weeks, and the maintenance phase, which for the purposes of the study will last 28 weeks.
DIETARY_SUPPLEMENT	Crohn's disease exclusion diet (CDED)	The original Crohn's disease exclusion diet, used as a comparator, is widely employed among first-line treatments in clinical practice for inducing remission in pediatric patients with Crohn's disease.

Timeline

• Start date: 2023-07-27
• Primary completion: 2025-07-27
• Completion: 2025-10-27
• First posted: 2024-03-22
• Last updated: 2024-03-22

Locations

3 sites across 1 country: Italy