Clinical Trials Logo
  1. Home
  2. Crohn Disease
  3. NCT06324513

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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04046913 - The ADDapt Diet in Reducing Crohn's Disease Inflammation N/A
Recruiting NCT05169593 - Prevention of Postoperative Endoscopic Recurrence With Endoscopy-driven Versus Systematic Biological Therapy Phase 4
Recruiting NCT06116604 - Early Bowel Resection for Terminal Ileal Crohn's Disease
Recruiting NCT05294107 - Intestinal Organoids N/A
Recruiting NCT05316584 - A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy N/A
Recruiting NCT05627128 - A Culturally Tailored Dietary Intervention to Treat Crohn's Disease N/A
Withdrawn NCT04349449 - ENTYVIO in Bio-naive Patients With Moderate/Severe Crohn's Disease (CD) in Daily Practice
Completed NCT05051943 - A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Completed NCT03058679 - Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission of Crohn's Disease N/A
Completed NCT02871635 - BI 695501 Versus Humira in Patients With Active Crohn's Disease: a Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity Phase 3
Recruiting NCT04539665 - Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease. N/A
Recruiting NCT04266600 - Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease N/A
Recruiting NCT03913572 - Treatment of Perianal Disease Using Adipose-derived Stem Cells
Completed NCT03606499 - Real-world Effectiveness of Ustekinumab in Participants Suffering From Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) With Extra-intestinal Manifestations or Immune-mediated Inflammatory Diseases
Completed NCT03668249 - A Study to Characterize Multidimensional Model to Predict the Course of Crohn's Disease (CD)
Terminated NCT04102111 - A Study Evaluating Participants With Moderately to Severely Active Crohn's Disease Phase 2
Recruiting NCT04997733 - Fecal Microbiota Transplantation in Crohn's Disease as Relay After Anti-TNF Withdrawal Phase 3
Recruiting NCT05906576 - Post-marketing Registry Study of Infliximab for Injection in Chinese Pediatric Crohn's Disease Patients Phase 4
Not yet recruiting NCT04398836 - Preoperative Nutrition for Crohn's Disease Patients Phase 3
Not yet recruiting NCT04502303 - 18F-FDG and 68Ga-FAPI PET/CT in Crohn's Disease Phase 2