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

michal roll

Status: Unknown

Conditions: Crohn's Disease

Treatments: Behavioral: Low residue diet; Behavioral: Mediterranean diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02825316

0569-15TLV

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Group A

Experimental group

Description:

Patients with active Crohn's disease that will be allocated to the Mediterranean diet group.

Treatment:

Behavioral: Mediterranean diet

Group B

Experimental group

Description:

Patients with active Crohn's disease that will be allocated to the low residue diet group.

Treatment:

Behavioral: Low residue diet