Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2025-12-29 @ 7:23 AM
Study NCT ID:
NCT06764550
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-08
First Post:
2025-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Molecular and Microbiota Signatures Underlying Colonic Diverticular Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043963', 'term': 'Diverticulosis, Colonic'}], 'ancestors': [{'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Colonic biopsies'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-02', 'studyFirstSubmitDate': '2025-01-02', 'studyFirstSubmitQcDate': '2025-01-02', 'lastUpdatePostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess the interaction between host factors and gut microbiota', 'timeFrame': '3 years', 'description': 'Assess the interaction between host factors and gut microbiota'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diverticular Disease of Colon']}, 'descriptionModule': {'briefSummary': 'The pathogenesis of diverticular disease is likely multifactorial in origin. This project aims to study the involvement of environmental factors in the pathophysiology of diverticular disease, the underlying molecular mechanisms, and alterations in the microbiota.', 'detailedDescription': 'The pathogenesis of diverticular disease is likely multifactorial in origin. Some studies have demonstrated the role of genetic factors, while others have highlighted the role of environmental factors. The present project aims to study the involvement of environmental factors in the pathophysiology of diverticular disease, the underlying molecular mechanisms, and alterations in the microbiota.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects were recruited from the endoscopy room.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 75 years.\n* Belonging to one of the following groups:\n\n 1. Patients with diverticula of the colon without symptoms.\n 2. Patients symptomatic for diverticular disease.\n 3. Subjects undergoing colonoscopy for colorectal cancer prevention or follow-up of previous polypectomies, asymptomatic for digestive symptoms.\n* Obtaining informed consent.\n\nExclusion Criteria:\n\n* Acute complicated diverticulitis (bleeding, perforation)\n* Previous colon surgery\n* Antibiotics or laxatives within the past 90 days\n* Pregnancy and/or lactation\n* Systemic and psychiatric disorders\n* Asthma, food allergies and other allergic-type disorders\n* Possible diseases leading to intestinal bacterial contamination (diabetes, blind loop syndrome, rheumatologic diseases).'}, 'identificationModule': {'nctId': 'NCT06764550', 'acronym': 'GR-Barbaro', 'briefTitle': 'Molecular and Microbiota Signatures Underlying Colonic Diverticular Disease', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}, 'officialTitle': 'Molecular and Microbiota Signatures Underlying Colonic Diverticular Disease - Caratterizzazione Dei Meccanismi Molecolari e Del Microbiota Nella Malattia Diverticolare Del Colon', 'orgStudyIdInfo': {'id': 'GR-Barbaro'}, 'secondaryIdInfos': [{'id': 'GR-2018-12367062', 'type': 'OTHER_GRANT', 'domain': 'Ministero della Salute'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy subjects', 'description': 'Subjects who are asymptomatic for digestive symptoms and without diverticula.', 'interventionNames': ['Other: This is an observational study, participants are not assigned an intervention as part of the study.']}, {'label': 'Patients with diverticulosis', 'description': 'Patients with diverticula and without symptoms.', 'interventionNames': ['Other: This is an observational study, participants are not assigned an intervention as part of the study.']}, {'label': 'Patients with symptomatic uncomplicated diverticular disease', 'description': 'Patients with diverticula and with symptoms.', 'interventionNames': ['Other: This is an observational study, participants are not assigned an intervention as part of the study.']}], 'interventions': [{'name': 'This is an observational study, participants are not assigned an intervention as part of the study.', 'type': 'OTHER', 'description': 'This is an observational study, participants are not assigned an intervention as part of the study.', 'armGroupLabels': ['Healthy subjects', 'Patients with diverticulosis', 'Patients with symptomatic uncomplicated diverticular disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40138', 'city': 'Bologna', 'country': 'Italy', 'facility': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'overallOfficials': [{'name': 'Maria Raffaella Barbaro, Biologist', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}