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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Patients with active Crohn's disease that will be allocated to the Mediterranean diet group. |
|
| Group B | Experimental | Patients with active Crohn's disease that will be allocated to the low residue diet group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mediterranean diet | Behavioral | Eight weeks course of Mediterranean diet (rich in plant-based food and low in animal protein and fat). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Crohn's Disease Activity Index (CDAI) | Change from baseline | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| C-reactive protein | Change from baseline | 8 weeks |
| Fecal calprotectin | Change from baseline | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lihi Godny, B.Sc | Contact | 97236947305 | lihigodny@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Iris Dotan, MD | Head, IBD Center, Department of Gastroenterology and Liver Diseases Tel Aviv Sourasky Medical Center | Principal Investigator |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D038441 | Diet, Mediterranean |
| ID | Term |
|---|---|
| D000095500 | Diet, Plant-Based |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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| 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). |
|
| 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 |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |