Mediterranean Diet as an add-on Therapy for Induction of Remission in Patients With Active Crohn's Disease

Study Overview
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Brief Summary
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This clinical study is designed to evaluate the effect of Mediterranean diet as an add-on therapy for induction of remission in adult patients with active Crohn's disease and to evaluate its effects on clinical, inflammatory and microbial parameters.

Detailed Description
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The Mediterranean diet has been associated with anti-inflammatory properties and with decreased risk for several chronic diseases. However, the effect of Mediterranean diet has not been evaluated in patients with inflammatory bowel diseases. The purpose of this study is to determine whether Mediterranean diet is superior to a low residue diet as an add-on therapy for induction of remission in adult patients with active Crohn's disease and to evaluate its effects on clinical, inflammatory and microbial parameters. Seventy eligible patients will be randomly assigned to one of two dietary interventions: Mediterranean diet or low residue diet, as an add-on therapy for induction of remission of active Crohn's disease. The effect of the dietary regimens on clinical, inflammatory and microbial parameters will be assessed at 8 and 52 weeks.

Official Title
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Mediterranean Diet vs. Low Residue Diet as an add-on Therapy for Induction of Remission in Patients With Active Crohn's Disease

Conditions
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Crohn's Disease

Intervention / Treatment
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* Behavioral: Mediterranean diet
* Behavioral: Low residue diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females Age: 18-75 Diagnosis of Crohn's Disease Montreal classification- B1 CDAI: 150-450 + CRP>0.5 or fecal calprotectin >200 Induction therapy with corticosteroids, 5-ASA, AZA, 6-MP, MTX or biologic therapy Capacity to give informed consent Exclusion Criteria: Ileostomy or colostomy Exclusive enteral nutrition/ partial enteral nutrition History of or current severe systemic diseases History of admission due to bowel obstruction Positive Clostridium difficile toxin Positive Salmonella, Shigella, Campylobacter, stool culture Pregnancy or lactation Use of antibiotics or steroids one month prior to inclusion

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Patients with active Crohn's disease that will be allocated to the Mediterranean diet group. | Behavioral: Mediterranean diet<br>* Eight weeks course of Mediterranean diet (rich in plant-based food and low in animal protein and fat).<br>|
| Experimental: Group B<br>Patients with active Crohn's disease that will be allocated to the low residue diet group. | Behavioral: Low residue diet<br>* Eight weeks course of low residue diet (minimal consumption of foods that add residue to the stool, such as raw fruits, vegetables and seeds, as well as nuts, legumes and whole grains).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Crohn's Disease Activity Index (CDAI) | Change from baseline | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-reactive protein | Change from baseline | 8 weeks | 
| Fecal calprotectin | Change from baseline | 8 weeks | 
| Remission rate- CDAI<150 + normal CRP/ fecal calprotectin |  | 52 weeks | 
| Response rate- decrease in 70 points in CDAI + decreased CRP/ fecal calprotectin |  | 8 weeks | 
| Microbial composition |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn's disease, inflammatory bowel diseases, Mediterranean diet, microbiome