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The aim of this study is to test Eicosapentaenoic free fatty acid's effects on calprotectin levels in IBD patients in clinical remission. During the study fecal calprotectin levels will be measured every 3 months and clinical flares will be registered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eicosapentaenoic acid | Experimental | Subject with Cronn's Disease and/or Ulcerative colitis in clinical remission will receive 2 g/day of eicosapentaenoic acid for 6 months |
|
| Medium chain fatty acid (placebo) | Placebo Comparator | Subjects with Crohn's Disease and/or Ulcerative colitis will be receive 2 g/day of medium chain fatty acid for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eicosapentaenoic acid | Dietary Supplement | 30 subject with Crohn's Disease and/or Ulcerative Colitis in clinical remission but with fecal calprotectin value >150 μg/g will recive 2 g/day of Eicosapentaenoic acid for 6 months treatment. At 3 months and 6 months, fecal calprotectin and clinical activity (CDAI for Crohn's Disease and SCCAI for Ulcerative Colitis) will be measured. The effect of Eicosapentaenoic acid on fecal calprotectin level will be monitored. Clinical relapses will be considered during the study. |
| Measure | Description | Time Frame |
|---|---|---|
| changes in fecal calprotectin levels | baseline, 3 months and at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| number of clinical flares of diseases | at 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliero Universitaria Policlinico Sant'Orsola Malpighi | Bologna | Bologna | 40138 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29391271 | Derived | Scaioli E, Sartini A, Bellanova M, Campieri M, Festi D, Bazzoli F, Belluzzi A. Eicosapentaenoic Acid Reduces Fecal Levels of Calprotectin and Prevents Relapse in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2018 Aug;16(8):1268-1275.e2. doi: 10.1016/j.cgh.2018.01.036. Epub 2018 Jan 31. |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D015118 | Eicosapentaenoic Acid |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
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|
| Medium chain fatty acid (placebo) | Dietary Supplement | 30 subject with Crohn's Disease and/or Ulcerative Colitis in clinical remission but with fecal calprotectin value >150 μg/g will recive 2 g/day of medium chain fatty acids for 6 months treatment. At 3 months and 6 months, fecal calprotectin and clinical activity (CDAI for Crohn's Disease and SCCAI for Ulcerative Colitis) will be measured. |
|
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D008055 |
| Lipids |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |