Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2026-01-01 @ 12:23 AM
Study NCT ID:
NCT04552405
Status:
COMPLETED
Last Update Posted:
2020-09-17
First Post:
2020-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preventive Anti-inflammatory Diet to Reduce Gastro-intestinal Inflammation in FAP Patients: a Prospective Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011125', 'term': 'Adenomatous Polyposis Coli'}], 'ancestors': [{'id': 'D018256', 'term': 'Adenomatous Polyps'}, {'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D044483', 'term': 'Intestinal Polyposis'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2018-02-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-10', 'studyFirstSubmitDate': '2020-05-04', 'studyFirstSubmitQcDate': '2020-09-10', 'lastUpdatePostDateStruct': {'date': '2020-09-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate changes in calprotectin levels', 'timeFrame': 'baseline, at 3 months and 6 months post anti-inflammatory diet consumption.', 'description': 'Change from baseline in calprotectin levels at 3 months and 6 months post anti-inflammatory diet consumption.'}], 'secondaryOutcomes': [{'measure': 'Evaluate changes in circulatory inflammatory markers', 'timeFrame': 'baseline, at 3 months and 6 months post anti-inflammatory diet consumption.', 'description': 'Change from baseline in circulatory inflammatory markers at 3 months and 6 months post anti-inflammatory diet consumption.'}, {'measure': 'Evaluate the effect on polyps growth', 'timeFrame': 'baseline and 6 months post anti-inflammatory diet consumption', 'description': 'Evaluate the effect of the anti-inflammatory diet on polyps growth in the rectal stump (in terms of number of polyps)'}, {'measure': 'Evaluate changes in the number of diarrheal discharges', 'timeFrame': 'baseline, at 3 months and 6 months post anti-inflammatory diet consumption', 'description': 'Change from baseline in the number of diarrheal discharges at 3 months and 6 months post anti-inflammatory diet consumption'}, {'measure': 'Evaluate changes in the immune cell profile', 'timeFrame': 'baseline, at 3 months and 6 months post anti-inflammatory diet consumption', 'description': 'Change from baseline in the immune cell profile at 3 months and 6 months post anti-inflammatory diet consumption'}, {'measure': 'Evaluate changes in stool inflammatory markers', 'timeFrame': 'baseline, at 3 months and 6 months post anti-inflammatory diet consumption', 'description': 'Change from baseline in stool inflammatory markers at 3 months and 6 months post anti-inflammatory diet consumption'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['FAP', 'Familial Adenomatous Polyposis'], 'conditions': ['Familial Adenomatous Polyposis (FAP)']}, 'referencesModule': {'references': [{'pmid': '18194984', 'type': 'BACKGROUND', 'citation': 'Vasen HF, Moslein G, Alonso A, Aretz S, Bernstein I, Bertario L, Blanco I, Bulow S, Burn J, Capella G, Colas C, Engel C, Frayling I, Friedl W, Hes FJ, Hodgson S, Jarvinen H, Mecklin JP, Moller P, Myrhoi T, Nagengast FM, Parc Y, Phillips R, Clark SK, de Leon MP, Renkonen-Sinisalo L, Sampson JR, Stormorken A, Tejpar S, Thomas HJ, Wijnen J. Guidelines for the clinical management of familial adenomatous polyposis (FAP). Gut. 2008 May;57(5):704-13. doi: 10.1136/gut.2007.136127. Epub 2008 Jan 14.'}, {'pmid': '21530747', 'type': 'BACKGROUND', 'citation': 'Ullman TA, Itzkowitz SH. Intestinal inflammation and cancer. Gastroenterology. 2011 May;140(6):1807-16. doi: 10.1053/j.gastro.2011.01.057.'}, {'pmid': '8385741', 'type': 'BACKGROUND', 'citation': 'Giardiello FM, Hamilton SR, Krush AJ, Piantadosi S, Hylind LM, Celano P, Booker SV, Robinson CR, Offerhaus GJ. Treatment of colonic and rectal adenomas with sulindac in familial adenomatous polyposis. N Engl J Med. 1993 May 6;328(18):1313-6. doi: 10.1056/NEJM199305063281805.'}, {'pmid': '27346644', 'type': 'BACKGROUND', 'citation': 'Dolan KT, Chang EB. Diet, gut microbes, and the pathogenesis of inflammatory bowel diseases. Mol Nutr Food Res. 2017 Jan;61(1):10.1002/mnfr.201600129. doi: 10.1002/mnfr.201600129. 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Modulation of faecal miRNAs highlights the preventive effects of a Mediterranean low-inflammatory dietary intervention. Clin Nutr. 2024 Apr;43(4):951-959. doi: 10.1016/j.clnu.2024.02.023. Epub 2024 Feb 26.'}, {'pmid': '34253565', 'type': 'DERIVED', 'citation': 'Belfiore A, Ciniselli CM, Signoroni S, Gariboldi M, Mancini A, Rivoltini L, Morelli D, Masci E, Bruno E, Macciotta A, Ricci MT, Daveri E, Cattaneo L, Gargano G, Apolone G, Milione M, Verderio P, Pasanisi P, Vitellaro M. Preventive Anti-inflammatory Diet to Reduce Gastrointestinal Inflammation in Familial Adenomatous Polyposis Patients: A Prospective Pilot Study. Cancer Prev Res (Phila). 2021 Oct;14(10):963-972. doi: 10.1158/1940-6207.CAPR-21-0076. Epub 2021 Jul 12.'}]}, 'descriptionModule': {'briefSummary': 'Preventive anti-inflammatory diet to reduce gastro-intestinal inflammation in FAP patients: a prospective pilot study', 'detailedDescription': 'a prospective pilot study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- FAP patients carrying mutations in APC gene, submitted to prophylactic total colectomy/IRA (with rectum preservation) and that participate to the regular endoscopic surveillance program at IRCCS-INT.\n\nExclusion Criteria:\n\n* FAP patients taking NSAIDs and/or Omega 3\n* Patients who carried MUTYH germline mutations or had no APC mutation found.'}, 'identificationModule': {'nctId': 'NCT04552405', 'acronym': 'FAPPER', 'briefTitle': 'Preventive Anti-inflammatory Diet to Reduce Gastro-intestinal Inflammation in FAP Patients: a Prospective Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milano'}, 'officialTitle': 'Preventive Anti-inflammatory Diet to Reduce Gastro-intestinal Inflammation in FAP Patients: a Prospective Pilot Study', 'orgStudyIdInfo': {'id': 'INT 78/17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'FAP patients', 'description': 'FAP patients who underwent prophylactic total colectomy', 'interventionNames': ['Dietary Supplement: Anti-inflammatory Diet']}], 'interventions': [{'name': 'Anti-inflammatory Diet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'FAP individuals followed for 3 months a low-inflammatory diet', 'armGroupLabels': ['FAP patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20133', 'city': 'Milan', 'country': 'Italy', 'facility': 'Fondazione IRCCS Istituto Nazionale Tumori', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}], 'overallOfficials': [{'name': 'Marco Vitellaro, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione IRCCS ISTITUTO NAZIONALE TUMORI'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'It will be discussed later by the staff'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milano', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}