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This clinical study is designed to evaluate the effect of two dietary patterns, Mediterranean diet and the specific carbohydrate diet on clinical, inflammatory and microbial parameters in patients after pouch surgery and to assess the effect of a personal tailored diet, based on microbial profile, on disease outcomes and generate a predictive model for future interventions.
Increasing evidence exist regarding the role of diet in the pathogenesis of inflammatory bowel diseases. One possible mechanism for the effect of diet on intestinal inflammation is modification of the gut microbial composition. However, the relationship between diet, the microbiome and intestinal inflammation is still vague.
The investigators plan to perform a crossover clinical trial. Seventy ulcerative colitis patients post restorative proctocolectomy (pouch) will be randomly allocated into two short-term (one week) dietary interventions, the Mediterranean diet and the specific carbohydrate diet, to assess which diet has the required influence (i.e. increased diversity, decrease in specific pathobionts and increase in "anti-inflammatory" taxa) on the gut microbiome of each participant. Based on this assessment, each participant will be treated by a personally-tailored diet for up to one year, during which microbial composition, clinical parameters, and quality of life will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Patients will be allocated to 7 days of Mediterranean diet and then will cross over to 7 days of specific carbohydrate diet |
|
| Group B | Experimental | Patients will be allocated to 7 days of specific carbohydrate diet and then will cross over to 7 days of Mediterranean diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mediterranean diet | Behavioral | The Mediterranean diet is rich in complex carbohydrates and fibers and low in animal proteins and fats. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Microbial diversity | Shannon α-diversity index | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical score | Pouchitis Disease Activity Index (PDAI) | 7 days |
| C-reactive protein (CRP) | Inflammatory marker | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lihi Godny, B.Sc | Contact | +9723947305 | lihig@tlvmc.gov.il |
| Name | Affiliation | Role |
|---|---|---|
| Iris Dotan, MD | Head, IBD center, Department of gastroenterology and liver diseases, Tel Aviv Sourasky Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center | Tel Aviv | Israel |
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| Specific Carbohydrate Diet | Behavioral | The specific carbohydrate diet is a dietary program popular among patients with IBD. The diet allows carbohydrate foods consisting of mono-saccharides only, and excludes di-saccharides and most polysaccharides. |
|
| fecal calprotectin | Inflammatory marker | 7 days |
| Quality of life | Inflammatory bowel diseases questionnaire (IBDQ) | 7 days |
| Microbial composition | Change in the abundance of microbial taxa | 7 days |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003424 | Crohn Disease |
| 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 |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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