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The aim of this study is to test Eicosapentaenoic acid's effects on markers relevant to colorectal carcinogenesis, RNA and DNA profiles, and the possibility that Eicosapentaenoic Acid treatment might be associated with changes of the gut microbiota and metabolomic profiles in patients with long-standing ulcerative colitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eicosapentaenoic Acid | Experimental | Subjects with long-standing ulcerative colitis and meeting the inclusion criteria will receive 2 g/day of Eicosapentaenoic Acid as a supplement for 90 days |
|
| Normal controls | No Intervention | Five patients undergoing screening colonoscopy and polypectomy using biopsy forceps. Six biopsies of healthy mucosa will be collected at the time of colonoscopy. Faeces, urine and blood samples will be collected prior to performing colonoscopy. The samples will serve as healthy reference for the basic studies. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eicosapentaenoic Acid | Dietary Supplement | Twenty patients with long-standing ulcerative colitis undergoing the usual colonoscopic surveillance + biopsy sampling will be recruited. At entry six extra biopsy samples will be collected from the colon. We will also collect blood (for serum, plasma and red cells isolation), urine and stools. Subjects will then receive 2 g/day of Eicosapentaenoic Acid (ALFA ™, SLA Pharma AG, Switzerland) as a supplement for 90 days. At the end of the study each subject will undergo sigmoidoscopy for the collection of 6 biopsies. Blood, urine and stools will be obtained prior to the procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of RNA profiles (gene expression and micro RNA) from baseline | baseline and at 3 months | |
| Changes of DNA methylation profiles | baseline and 3 months | |
| Changes in cell proliferation | baseline and 3 months | |
| Changes of apoptosis | baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of circulating cytokines from baseline | baseline and 3 months | |
| Changes of membrane fatty acid composition from baseline | baseline and 3 months | |
| Changes of metabolomic profiles from baseline |
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Arm: experimental
Inclusion Criteria:
Exclusion Criteria:
Arm: no intervention
Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Luigi Ricciardiello, MD | Azienda Ospedaliero Universitaria Policlinico S.Orsola Malpighi | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliero Universitaria Policlinico Sant'Orsola Malpighi | Bologna | BO | 40138 | Italy |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| 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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|
|
| baseline and 3 months |
| Change of Microbiota composition from baseline | baseline and 3 months |
| 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 |