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

Not Applicable

• Conditions: Crohn's Disease
• Interventions: Behavioral: Mediterranean diet; Behavioral: Low residue diet

• Registration Number: NCT02825316
• Lead Sponsor: michal roll

Brief Summary

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

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.

Study Timeline

• Status Verified: 2016-06
• Study Start: 2016-07
• Study First Submitted: 2016-07-04
• Study First Submitted QC: 2016-07-04
• Last Update Submitted: 2016-07-04
• Study First Posted: 2016-07-07
• Last Update Posted: 2016-07-07
• Primary Completion: 2018-01
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Mediterranean diet	Patients with active Crohn's disease that will be allocated to the Mediterranean diet group.
Group B	Low residue diet	Patients with active Crohn's disease that will be allocated to the low residue diet group.

Primary Outcome Measures

Name	Time	Method
Crohn's Disease Activity Index (CDAI)	8 weeks	Change from baseline

Secondary Outcome Measures

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