Clinical trial NCT06324513: Evaluation of the Efficacy and Tolerability of the Mediterranean Diet Pattern in the Exclusion Diet for Patients With Crohn's Disease.
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Crohn Disease
Lead sponsor: Meyer Children's Hospital IRCCS
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 120
Sex: ALL
Minimum age (years): 4
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Patients with a stable diagnosis of Crohn's disease according to the criteria of the ECCO/ESPGHAN guidelines.
* Patients with a new diagnosis of the disease or with a disease diagnosed no more than three years ago, receiving stable pharmacological therapy for at least 2 months with immunomodulators (thiopurines, methotrexate, azathioprine) or biologic drugs who have experienced a disease relapse and require reinduction of remission.
* Mild to moderate disease activity assessed by the wPCDAI score between 12.5-57.5 in the pediatric population and a Harvey-Bradshaw Index ranging from 5 to 16 for the adult population.
* Biochemical evidence of active intestinal inflammation at enrollment, assessed by inflammatory markers such as C-reactive protein (CRP) levels ≥ 0.5 mg/dl or fecal calprotectin ≥ 150 mg/g.
* Ability to provide biological samples (stool and blood samples).

Exclusion Criteria:

* Monogenic disease;
* Disease with fibrostenotic or penetrating phenotype;
* Complex perianal fistulizing disease not completely in remission;
* Patients with ileostomy or who have undergone intestinal resection or colectomy;
* Patients currently undergoing other nutritional therapy (e.g., exclusive enteral nutrition) or who have undergone it in the last month;
* Patients not on stable therapy with immunomodulators or biologic drugs or who started therapy with thiopurines less than 4 weeks before enrollment, or methotrexate less than 8 weeks before enrollment;
* Patients with recent use of systemic steroids in the four weeks before enrollment or recent initiation or dose adjustment phase of therapy with immunomodulators (e.g., azathioprine, 6-mercaptopurine, or methotrexate) or biologic drugs;
* Pregnancy;
* Vegan or vegetarian patients;
* Celiac disease.

Primary outcomes:
measure: Clinical response to the first phase of diet
timeFrame: 8 weeks
measure: Clinical remission rate
timeFrame: 8 weeks
measure: Adherence rate to the Med-CDED diet and comparison to the original CDED both in pediatric and adult cohort
timeFrame: Anytime during the study
measure: Clinical remission rate in adult patients at the end of phase I of diet
timeFrame: 8 weeks
Secondary outcomes:
measure: Transmural response of the thickness of the intestinal loops both in pediatric and adult cohort
timeFrame: 0, 8, 24, 38 and 52 weeks
measure: Assessment of the reduction or normalization of inflammation markers both in pediatric and adult cohort
timeFrame: 8 weeks
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
timeFrame: 24 weeks
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
timeFrame: 52 weeks
measure: Endoscopic response rate obtained at 6 months both in pediatric and adult cohort
timeFrame: 0 and 26 weeks
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
timeFrame: 52 weeks
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
timeFrame: 52 weeks
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
timeFrame: 52 weeks
measure: Ability to maintain a healthy and balanced diet and patient satisfaction with the treatment both in pediatric and adult cohortreceived
timeFrame: Anytime during the study
Other outcomes:
Locations:
city: Firenze
country: Italy
facility: Meyer Children's Hospital IRCCS
city: Palermo
country: Italy
facility: Ospedali Riuniti Villa Sofia-Cervello
city: Roma
country: Italy
facility: Università La Sapienza di Roma
Study officials:
References: