protocolSection identificationModule nctId: NCT06324513, orgStudyIdInfo id: Med-CDED, briefTitle: Evaluation of the Efficacy and Tolerability of the Mediterranean Diet Pattern in the Exclusion Diet for Patients With Crohn's Disease., statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-27, primaryCompletionDateStruct date: 2025-07-27, completionDateStruct date: 2025-10-27, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Meyer Children's Hospital IRCCS, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Crohn Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Mediterranean Crohn's Disease Exclusion Diet (Med-CDED), interventions name: Crohn's disease exclusion diet (CDED), outcomesModule primaryOutcomes measure: Clinical response to the first phase of diet, primaryOutcomes measure: Clinical remission rate, primaryOutcomes measure: Adherence rate to the Med-CDED diet and comparison to the original CDED both in pediatric and adult cohort, primaryOutcomes measure: Clinical remission rate in adult patients at the end of phase I of diet, secondaryOutcomes measure: Transmural response of the thickness of the intestinal loops both in pediatric and adult cohort, secondaryOutcomes measure: Assessment of the reduction or normalization of inflammation markers both in pediatric and adult cohort, secondaryOutcomes measure: Assessment of clinical remission rate at the end of Phase II of the Med-CDED diet and comparision with the original CDED both in pediatric and adult cohort, secondaryOutcomes measure: Assessment of clinical remission rate at the end of Phase III of the Med-CDED diet and comparision with the original CDED both in pediatric and adult cohort, secondaryOutcomes measure: Endoscopic response rate obtained at 6 months both in pediatric and adult cohort, secondaryOutcomes measure: Assessment of the modification of the intestinal microbiota composition (trough alpha and beta diversity) at the end of the various phases of the Med-CDED and comparison with the original CDED both in pediatric and adult cohort, secondaryOutcomes measure: Assessment of the metabolome profiles at the end of the various phases of the Med-CDED and comparison with the original CDED both in pediatric and adult cohort, secondaryOutcomes measure: Assessment of the trascriptome profiles at the end of the various phases of the Med-CDED and comparison with the original CDED both in pediatric and adult cohort, secondaryOutcomes measure: Ability to maintain a healthy and balanced diet and patient satisfaction with the treatment both in pediatric and adult cohortreceived, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 65 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Meyer Children's Hospital IRCCS, status: RECRUITING, city: Firenze, country: Italy, contacts name: Paolo Lionetti, role: CONTACT, email: paolo.lionetti@meyer.it, geoPoint lat: 43.77925, lon: 11.24626, locations facility: Ospedali Riuniti Villa Sofia-Cervello, status: RECRUITING, city: Palermo, country: Italy, contacts name: Ambrogio Orlando, role: CONTACT, email: ambrogiorlando@gmail.com, geoPoint lat: 38.13205, lon: 13.33561, locations facility: Università La Sapienza di Roma, status: RECRUITING, city: Roma, country: Italy, contacts name: Salvatore Oliva, role: CONTACT, email: salvatore.oliva@uniroma1.it, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False