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
|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease||Behavioral: Mediterranean diet Behavioral: Low residue diet||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|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|
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).
- Crohn's Disease Activity Index (CDAI) [ Time Frame: 8 weeks ]Change from baseline
- C-reactive protein [ Time Frame: 8 weeks ]Change from baseline
- Fecal calprotectin [ Time Frame: 8 weeks ]Change from baseline
- Remission rate- CDAI<150 + normal CRP/ fecal calprotectin [ Time Frame: 52 weeks ]
- Response rate- decrease in 70 points in CDAI + decreased CRP/ fecal calprotectin [ Time Frame: 8 weeks ]
- Microbial composition [ Time Frame: 8 weeks ]
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
|Contact: Lihi Godny, B.Scfirstname.lastname@example.org|
|Principal Investigator:||Iris Dotan, MD||Head, IBD Center, Department of Gastroenterology and Liver Diseases Tel Aviv Sourasky Medical Center|