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

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ClinicalTrials.gov Identifier: NCT02825316
Recruitment Status : Unknown
Verified June 2016 by michal roll, Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : July 7, 2016
Last Update Posted : July 7, 2016
Sponsor:
Information provided by (Responsible Party):
michal roll, Tel-Aviv Sourasky Medical Center

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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Behavioral: Mediterranean diet Behavioral: Low residue diet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Mediterranean Diet vs. Low Residue Diet as an add-on Therapy for Induction of Remission in Patients With Active Crohn's Disease
Study Start Date : July 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

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).




Primary Outcome Measures :
  1. Crohn's Disease Activity Index (CDAI) [ Time Frame: 8 weeks ]
    Change from baseline


Secondary Outcome Measures :
  1. C-reactive protein [ Time Frame: 8 weeks ]
    Change from baseline

  2. Fecal calprotectin [ Time Frame: 8 weeks ]
    Change from baseline

  3. Remission rate- CDAI<150 + normal CRP/ fecal calprotectin [ Time Frame: 52 weeks ]
  4. Response rate- decrease in 70 points in CDAI + decreased CRP/ fecal calprotectin [ Time Frame: 8 weeks ]
  5. Microbial composition [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02825316


Contacts
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Contact: Lihi Godny, B.Sc 97236947305 lihigodny@gmail.com

Sponsors and Collaborators
michal roll
Investigators
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Principal Investigator: Iris Dotan, MD Head, IBD Center, Department of Gastroenterology and Liver Diseases Tel Aviv Sourasky Medical Center
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Responsible Party: michal roll, PhD, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT02825316    
Other Study ID Numbers: 0569-15TLV
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: July 7, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by michal roll, Tel-Aviv Sourasky Medical Center:
Crohn's disease
inflammatory bowel diseases
Mediterranean diet
microbiome
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases