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

NCT06324513 | Recruiting

• 1 other identifier: Med-CDED
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

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.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (4)

• Clinical response to the first phase of diet

  reduction of 12.5 points in the wPCDAI score.

  8 weeks

• Clinical remission rate

  wPCDAI score must be \<12.5 points after the first phase of diet

  8 weeks

• Adherence rate to the Med-CDED diet and comparison to the original CDED both in pediatric and adult cohort

  Adherence rate will be assessed by adherence questionnaire score or by considering the number of patients who refuse the diet

  Anytime during the study

• Clinical remission rate in adult patients at the end of phase I of diet

  Clinical remission will be assessed by HBI \< 5 points

  8 weeks

Secondary Outcomes (9)

• Transmural response of the thickness of the intestinal loops both in pediatric and adult cohort

  0, 8, 24, 38 and 52 weeks

• Assessment of the reduction or normalization of inflammation markers both in pediatric and adult cohort

  8 weeks

• 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

  24 weeks

• 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

  52 weeks

• Endoscopic response rate obtained at 6 months both in pediatric and adult cohort

  0 and 26 weeks

Study Arms (2)

Med-CDED

EXPERIMENTAL

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: Mediterranean Crohn's Disease Exclusion Diet (Med-CDED)

CDED

ACTIVE COMPARATOR

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

Dietary Supplement: Crohn's disease exclusion diet (CDED)

Interventions

Mediterranean Crohn's Disease Exclusion Diet (Med-CDED) DIETARY_SUPPLEMENT

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.

Med-CDED

Crohn's disease exclusion diet (CDED) DIETARY_SUPPLEMENT

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.

CDED

Eligibility Criteria

• Age: 4 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Meyer Children's Hospital IRCCS: lead

Study Sites (3)

Meyer Children's Hospital IRCCS

Florence, Italy

RECRUITING

Ospedali Riuniti Villa Sofia-Cervello

Palermo, Italy

RECRUITING

Università La Sapienza di Roma

Roma, Italy

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Paolo Lionetti, MD

CONTACT

3398416059; paolo.lionetti@meyer.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: March 22, 2024
• Study Start: July 27, 2023
• Primary Completion: July 27, 2025
• Study Completion: October 27, 2025
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)