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

July 4, 2016 updated by: michal roll

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: 8 weeks
Change from baseline
8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0569-15TLV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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