Mediterranean Diet as an add-on Therapy for Induction of Remission in Patients With Active Crohn's Disease
NCT ID: NCT02825316
Last Updated: 2016-07-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2016-07-31
2019-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group A
Patients with active Crohn's disease that will be allocated to the Mediterranean diet group.
Mediterranean diet
Eight weeks course of Mediterranean diet (rich in plant-based food and low in animal protein and fat).
Group B
Patients with active Crohn's disease that will be allocated to the low residue diet group.
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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michal roll
OTHER_GOV
Responsible Party
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michal roll
PhD
Principal Investigators
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Iris Dotan, MD
Role: PRINCIPAL_INVESTIGATOR
Head, IBD Center, Department of Gastroenterology and Liver Diseases Tel Aviv Sourasky Medical Center
Central Contacts
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Other Identifiers
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0569-15TLV
Identifier Type: -
Identifier Source: org_study_id
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