Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-01-01 @ 5:59 AM
Study NCT ID:
NCT04869956
Status:
UNKNOWN
Last Update Posted:
2022-07-27
First Post:
2021-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gut Microbiome Modification Through Dietary Intervention in Patients With Colorectal Cancer: Response to Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}], 'ancestors': [{'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'open, controlled, randomized clinical trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-25', 'studyFirstSubmitDate': '2021-04-28', 'studyFirstSubmitQcDate': '2021-04-28', 'lastUpdatePostDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of anastomotic leakage', 'timeFrame': '360 Days from Baseline', 'description': 'Number of anastomotic leakage'}, {'measure': 'Surgical site infection', 'timeFrame': '360 Days from Baseline', 'description': 'Number of site infection'}], 'secondaryOutcomes': [{'measure': 'Change in gut microbiome composition', 'timeFrame': '360 Days from Baseline', 'description': 'changes in gut microbiota composition by 16S rRNA gene sequencing'}, {'measure': 'Serum levels of inflammation markers', 'timeFrame': '360 Days from Baseline', 'description': 'Blood samples will be used to determine markers of inflammation (IL-6, IL-1β, IL-10 and TNFα), and markers of intestinal permeability (zonulin)'}, {'measure': 'Length of hospitalization after surgery', 'timeFrame': '360 Days from Baseline', 'description': 'Number of days'}, {'measure': 'Recurrences of CRC after surgery', 'timeFrame': '360 Days from Baseline', 'description': 'Number of recurrences'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Microbiome', 'Surgery'], 'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'The investigators will conduct an open, controlled, randomized clinical trial, in patients with scheduled surgical intervention for CRC in the General Surgery and Digestive System Unit of the Virgen de la Arrixaca University Hospital (Murcia, Spain). All the included individuals must have passed the protocol of the Virgen de la Arrixaca University Hospital to be candidates for elective major surgery for CRC and must sign the informed consent after being informed of the objectives and the methodology of the study. The Helsinki Declaration will be followed during the duration of the project.\n\nPatients will be randomized in a 1:1 ratio after receiving a diagnosis of CRC in the endoscopic evaluation; in the control arm, patients will receive standard nutritional recommendations, while patients in the intervention arm will be advised to follow a high-fiber diet rich in PUFAs (total dietary intake of at least 30 grams of fiber per day, and of at least 3 grams of PUFAs per day from food, not supplements) at least 4 weeks before surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18-80 years old.\n* After clinical diagnosis of CRC (stage I-III), the doctor has recommended and arranged for CRC surgery\n\nExclusion Criteria:\n\n* Clinical diagnosis of stage IV CRC.\n* Current gastrointestinal illness other than gastroesophageal reflux disease or hemorrhoids (such as celiac disease, inflammatory bowel disease, malabsorptive bariatric procedures, etc.).\n* Chronic liver or kidney disease.\n* History of cardiac disease.\n* Positive genetic test for inherited polyposis syndromes (such as familial adenomatous polyps, hereditary non-polyposis colon cancer syndromes, etc).\n* Alcoholism or illicit drug use.\n* Antibiotic use within the past 2 months.\n* Dietary supplement use including pre- or probiotics within the past month.\n* History of intestinal cancer, inflammatory bowel disease, celiac disease, or malabsorptive bariatric surgery.\n* Inflammatory or connective tissue disease (such as lupus, scleroderma, rheumatoid arthritis, etc.).'}, 'identificationModule': {'nctId': 'NCT04869956', 'briefTitle': 'Gut Microbiome Modification Through Dietary Intervention in Patients With Colorectal Cancer: Response to Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia'}, 'officialTitle': 'Gut Microbiome Modification Through Dietary Intervention in Patients With Colorectal Cancer: Response to Surgery', 'orgStudyIdInfo': {'id': '2021-2-7-HCUVA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Standard diet', 'description': 'Dietary pattern: Standard diet', 'interventionNames': ['Other: Dietary pattern: Standard diet']}, {'type': 'EXPERIMENTAL', 'label': 'High - Fiber diet rich in PUFA', 'description': 'High - Fiber diet rich in PUFA', 'interventionNames': ['Other: Dietary pattern : High-fiber diet rich in PUFA']}], 'interventions': [{'name': 'Dietary pattern : High-fiber diet rich in PUFA', 'type': 'OTHER', 'description': 'High-fiber diet rich in PUFAs (total dietary intake of at least 30 grams of fiber per day, and of at least 3 grams of PUFAs per day from food, not supplements) at least 4 weeks before surgery', 'armGroupLabels': ['High - Fiber diet rich in PUFA']}, {'name': 'Dietary pattern: Standard diet', 'type': 'OTHER', 'description': 'standard nutritional recommendations', 'armGroupLabels': ['Standard diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30120', 'city': 'Murcia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Bruno Ramos Molina', 'role': 'CONTACT', 'email': 'bruno.ramos@imib.es'}], 'facility': 'Biomedical Research Institute of Murcia (IMIB-Arrixaca)', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}], 'centralContacts': [{'name': 'Bruno Ramos Molina', 'role': 'CONTACT', 'email': 'bruno.ramos@imib.es', 'phone': '968369500'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}