Evaluating the Mediterranean diet for Crohn's disease management

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.

This study is testing if a modified Mediterranean diet can help people with Crohn's disease feel better by keeping out foods that might cause inflammation while still getting the diet's health benefits.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 4 Years to 65 Years
• Sex: All
• Sponsor: Meyer Children's Hospital IRCCS (Academic / other)
• Drugs / interventions: methotrexate
• Locations: 3 sites (Firenze and 2 other locations)
• Trial ID: NCT06324513 on ClinicalTrials.gov

What this trial studies

This study aims to assess how well the Mediterranean diet can be adapted for patients with Crohn's disease while maintaining the core principles of the Crohn's disease exclusion diet (CDED). The focus is on excluding ultra-processed foods that may trigger inflammation, while integrating the Mediterranean diet's anti-inflammatory benefits. The study will evaluate both the efficacy and tolerability of this modified diet, with the goal of improving patient adherence to dietary recommendations and overall health outcomes. It will also incorporate multi-omic investigations to analyze the impact of diet on the microbiome and other biological factors.

Who should consider this trial

Good fit: Ideal candidates include patients with a stable diagnosis of Crohn's disease who are on stable pharmacological therapy and have mild to moderate disease activity.

Not a fit: Patients with monogenic diseases or those with fibrostenotic or penetrating phenotypes may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance dietary compliance and improve health outcomes for patients with Crohn's disease.

How similar studies have performed: While the Mediterranean diet has shown promise in other contexts, this specific adaptation for Crohn's disease is novel and has not been extensively tested.

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.

Where this trial is running

Firenze and 2 other locations

• Meyer Children's Hospital IRCCS — Firenze, Italy (Recruiting)
• Ospedali Riuniti Villa Sofia-Cervello — Palermo, Italy (Recruiting)
• Università La Sapienza di Roma — Roma, Italy (Recruiting)

Study contacts

• Study coordinator: Paolo Lionetti, MD

Conditions Crohn Disease