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

Crohn's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02825316
• Other study ID #: 0569-15TLV
• Status: Not yet recruiting
• Phase: N/A
• First received: July 4, 2016
• Last updated: July 4, 2016
• Start date: July 2016
• Est. completion date: January 2019

Study information

• Verified date: June 2016
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Lihi Godny, B.Sc
• Phone: 97236947305
• Email: lihigodny[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 2019
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Behavioral:
• Mediterranean diet
Eight weeks course of Mediterranean diet (rich in plant-based food and low in animal protein and fat).
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
michal roll

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Crohn's Disease Activity Index (CDAI)	Change from baseline	8 weeks	No
Secondary	C-reactive protein	Change from baseline	8 weeks	No
Secondary	Fecal calprotectin	Change from baseline	8 weeks	No
Secondary	Remission rate- CDAI<150 + normal CRP/ fecal calprotectin		52 weeks	No
Secondary	Response rate- decrease in 70 points in CDAI + decreased CRP/ fecal calprotectin		8 weeks	No
Secondary	Microbial composition		8 weeks	No