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

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

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.

Study Overview

• Status: Unknown
• Conditions: Crohn's Disease
• Intervention / Treatment: Behavioral: Mediterranean diet; Behavioral: Low residue diet

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group A; Patients with active Crohn's disease that will be allocated to the Mediterranean diet group.	Behavioral: Mediterranean diet; Eight weeks course of Mediterranean diet (rich in plant-based food and low in animal protein and fat).
EXPERIMENTAL: Group B; Patients with active Crohn's disease that will be allocated to the low residue diet group.	Behavioral: Low residue diet; 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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: michal roll
• Investigators: Principal Investigator: Iris Dotan, MD, Head, IBD Center, Department of Gastroenterology and Liver Diseases Tel Aviv Sourasky Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (ANTICIPATED): January 1, 2018
• Study Completion (ANTICIPATED): January 1, 2019

Study Registration Dates

• First Submitted: July 4, 2016
• First Submitted That Met QC Criteria: July 4, 2016
• First Posted (ESTIMATE): July 7, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): July 7, 2016
• Last Update Submitted That Met QC Criteria: July 4, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Crohn's disease; microbiome; Mediterranean diet; inflammatory bowel diseases
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: 0569-15TLV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO