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Small bowel dysbiosis (SBD), is a frequent finding in subjects with irritable bowel syndrome (IBS). The formula-tion in sunflower lecithin (Phytosome) of Curcuma longa and Boswellia serrata demonstrated beneficial effects on intestinal microbiota. The aim of this study was to evaluate the effect of a lecithin-based delivery formulation of Curcuma longa and of Boswellia serrata extracts (CUBO), on SBD in IBS subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CUBO and low FODMAP diet (Intervention) | Active Comparator | Curcuma and Boswellia serrata extract plus a Low Fodmap Diet |
|
| LFD (Control) | Other | Only Low Fodmap Diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Curcuma and boswellia extracts plus low fodmap diet | Dietary Supplement | Low Foodmap diet + Curcuma and boswellia extracts both formulated in sunflower lecithin (Phytosomeâ„¢) and processed with a strong commitment to sustainability |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the effect of Lecithin formulation on small bowel dysbiosis | The primary endpoint was the change of small bowel dysbiosis established by the decrease in urine indican values. The dysbiosis of the small bowel was defined by increased urinary indican values with normal values of urinary skatole. Urinary values of indican (3-indoxyl sulfate) were evaluated through a colorimetric method. Urinary indican was considered normal when the levels were lower than 10 mg/L. | from baseline to 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mariangela Rondanelli | Pavia | PV | 27100 | Italy |
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| Low Foodmap diet | Other | such as lactose or gluten free diet in the last 6 months |
|
| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| D064806 | Dysbiosis |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C012596 | turmeric extract |
| D000092622 | FODMAP Diet |
| ID | Term |
|---|---|
| D000092724 | Elimination Diets |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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