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

NCT02825316 | Unknown

• 1 other identifier: 0569-15TLV
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Crohn's Disease

Keywords

Crohn's disease; inflammatory bowel diseases; Mediterranean diet; microbiome

Outcome Measures

Primary Outcomes (1)

• Crohn's Disease Activity Index (CDAI)

  Change from baseline

  8 weeks

Secondary Outcomes (5)

• C-reactive protein

  8 weeks

• Fecal calprotectin

  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

Study Arms (2)

Group A

EXPERIMENTAL

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

Behavioral: Mediterranean diet

Group B

EXPERIMENTAL

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

Behavioral: Low residue diet

Interventions

Mediterranean diet BEHAVIORAL

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

Group A

Low residue diet BEHAVIORAL

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).

Group B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• michal roll: lead

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Iris Dotan, MD

  Head, IBD Center, Department of Gastroenterology and Liver Diseases Tel Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lihi Godny, B.Sc

CONTACT

97236947305; lihigodny@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: July 4, 2016
• First Posted: July 7, 2016
• Study Start: July 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2019
• Last Updated: July 7, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share