Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2026-01-03 @ 12:33 AM
Study NCT ID:
NCT02069561
Status:
COMPLETED
Last Update Posted:
2015-09-18
First Post:
2014-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Eicosapentaenoic Acid on Subjects at High Risk for Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015118', 'term': 'Eicosapentaenoic Acid'}], 'ancestors': [{'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}, {'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D009821', 'term': 'Oils'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'lastUpdateSubmitDate': '2015-09-17', 'studyFirstSubmitDate': '2014-02-19', 'studyFirstSubmitQcDate': '2014-02-20', 'lastUpdatePostDateStruct': {'date': '2015-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of RNA profiles (gene expression and micro RNA) from baseline', 'timeFrame': 'baseline and at 3 months'}, {'measure': 'Changes of DNA methylation profiles', 'timeFrame': 'baseline and 3 months'}, {'measure': 'Changes in cell proliferation', 'timeFrame': 'baseline and 3 months'}, {'measure': 'Changes of apoptosis', 'timeFrame': 'baseline and 3 months'}], 'secondaryOutcomes': [{'measure': 'Changes of circulating cytokines from baseline', 'timeFrame': 'baseline and 3 months'}, {'measure': 'Changes of membrane fatty acid composition from baseline', 'timeFrame': 'baseline and 3 months'}, {'measure': 'Changes of metabolomic profiles from baseline', 'timeFrame': 'baseline and 3 months'}, {'measure': 'Change of Microbiota composition from baseline', 'timeFrame': 'baseline and 3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Arm: experimental\n\nInclusion Criteria:\n\n* Patients with ulcerative colitis (diagnosed based on clinical criteria, endoscopic and histological) lasting over 8 years, with no clinical activity (SCCAI = 0), and in stable treatment (without any change in treatment in the previous 3 months) with mesalamine, immunomodulators and / or biologics.\n* Baseline fecal calprotectin\\> 150 micrograms / g.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Patients receiving systemic steroids in the two months prior to study entry.\n* Patients taking concomitant warfarin or other blood thinners.\n* Known or suspected hypersensitivity to eicosapentaenoic acid/omega 3.\n* Women who are pregnant or of childbearing age who do not accept the use of contraceptive methods specified in the study (oral contraception, IUDs) and breastfeeding women.\n* Patients with severe medical conditions that, in the opinion of the investigator, contraindicate the patient's participation in the study.\n* Changes of treatments and / or use of experimental drugs within 3 months before inclusion in the study.\n* Use of Probiotics\n\nArm: no intervention\n\nInclusion criteria\n\n* Subjects undergoing screening colonoscopy within the regional colorectal cancer screening programme\n* Signed informed consent\n* Polypectomy with biopsy forceps.\n\nExclusion criteria\n\n* HBV-positive, HCV-positive, HIV-positive or otherwise affected by infectious diseases\n* Subjects undergoing chemo and radiation therapy within six months prior to surgery\n* Patients receiving systemic steroid in the two months prior to study entry\n* Patients undergoing antibiotic therapy within three months prior to the study\n* Patients treated with probiotics"}, 'identificationModule': {'nctId': 'NCT02069561', 'acronym': 'EPAUC', 'briefTitle': 'Effects of Eicosapentaenoic Acid on Subjects at High Risk for Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}, 'officialTitle': 'Effects of Eicosapentaenoic Acid on Molecular, Metabonomics and Intestinal Microbiota Changes, in Subjects With Long-standing Inflammatory Bowel Disease', 'orgStudyIdInfo': {'id': 'EPAUC/2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Eicosapentaenoic Acid', 'description': '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', 'interventionNames': ['Dietary Supplement: Eicosapentaenoic Acid']}, {'type': 'NO_INTERVENTION', 'label': 'Normal controls', 'description': '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.'}], 'interventions': [{'name': 'Eicosapentaenoic Acid', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['ALFA ™'], 'description': '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.', 'armGroupLabels': ['Eicosapentaenoic Acid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40138', 'city': 'Bologna', 'state': 'BO', 'country': 'Italy', 'facility': "Azienda Ospedaliero Universitaria Policlinico Sant'Orsola Malpighi", 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'overallOfficials': [{'name': 'Luigi Ricciardiello, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Azienda Ospedaliero Universitaria Policlinico S.Orsola Malpighi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Gastroenterology', 'investigatorFullName': 'Luigi Ricciardiello', 'investigatorAffiliation': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}}}}