Ignite Creation Date:
2025-12-24 @ 6:27 PM
Ignite Modification Date:
2026-01-02 @ 3:11 AM
Study NCT ID:
NCT06919068
Status:
RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Examination of the Large Intestine With Camera Capsule in Patients With Blood Stream Infection With Gut-associated Bacteria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D016470', 'term': 'Bacteremia'}], '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'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004724', 'term': 'Endoscopy'}], 'ancestors': [{'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-04-02', 'studyFirstSubmitQcDate': '2025-04-02', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Colorectal cancer and precancerous tumors', 'timeFrame': '4-8 weeks after hospitalization with anaerobic gut-associated bacteria', 'description': 'Prevalence of colorectal cancer and precancerous tumors using colon capsule endoscopy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colorectal Cancer', 'Anaerobic bacteria', 'Bacteria, anaerobic', 'Cancer, colorectal', 'Bacteremia', 'Blood stream infection', 'Colon capsule endoscopy'], 'conditions': ['Colorectal Cancer (CRC)', 'Colorectal Cancer and Pre-cancer Polyps', 'Blood Stream Infection', 'Anaerobic Infection', 'Bacteriaemia']}, 'referencesModule': {'references': [{'pmid': '37230400', 'type': 'BACKGROUND', 'citation': 'Laupland KB, Edwards F, Furuya-Kanamori L, Paterson DL, Harris PNA. Bloodstream Infection and Colorectal Cancer Risk in Queensland Australia, 2000-2019. Am J Med. 2023 Sep;136(9):896-901. doi: 10.1016/j.amjmed.2023.05.003. Epub 2023 May 23.'}, {'pmid': '35380653', 'type': 'BACKGROUND', 'citation': 'Justesen US, Nielsen SL, Jensen TG, Dessau RB, Moller JK, Coia JE, Andersen SL, Pedersen C, Gradel KO. Bacteremia With Anaerobic Bacteria and Association With Colorectal Cancer: A Population-based Cohort Study. Clin Infect Dis. 2022 Nov 14;75(10):1747-1753. doi: 10.1093/cid/ciac259.'}, {'pmid': '38960102', 'type': 'BACKGROUND', 'citation': 'Justesen US, Ellebaek MB, Qvist N, Iachina M, Frimodt-Moller N, Soes LM, Skovgaard S, Lemming L, Samulioniene J, Andersen SL, Dessau RB, Moller JK, Coia JE, Gradel KO. Colorectal cancer and association with anaerobic bacteraemia: A Danish nationwide population-based cohort study. J Infect. 2024 Aug;89(2):106212. doi: 10.1016/j.jinf.2024.106212. Epub 2024 Jul 2.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to diagnose colorectal cancer or precancerous tumors in participants over the age of 18 hospitalized with blood stream infection with anaerobic gut-associated bacteria. The main question it aims to answer is:\n\n• How prevalent is cancer and precancerous tumors in the large intestines and rectum in patients with anaerobic bacteremia? Participants will be offered an examination using colon capsule endoscopy 4-8 weeks after discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to Odense University Hospital with anaerobic blood stream infection.\n\nPatients who are discharged before result of blood culture with anaerobic gut-associated bacteria, will be contacted by letter and offered participation in the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Older than 18 years\n* Blood culture with growth of one or more of the following bacterial genera Bacteroides, Clostridium, Filifactor, Fusobacterium, Gemella, Granulicatella, Parvimonas, Peptostreptococcus, Prevotella, Solobacterium, Peptoniphilus, Ruminococcus, Finegoldia and Streptococcus.\n* Able to provide oral and written informed consent\n* Able to read and speak Danish\n\nExclusion Criteria:\n\n* Prior colorectal cancer diagnosis\n* History of stenosis of the gastrointestinal tract\n* Previous treatment of inflammatory bowel disease\n* Previous major surgery of the gastrointesinal tract (e.g. gastric bypass)\n* Colostomy\n* Pacemaker/ICD\n* Pregnancy or breastfeeding\n* Allergies to the bowel preparation regimen\n* Severe kidney disease\n* Focus of infection in skin and soft tissue or outside the truncus (e.g. decubitus, diabetic foot ulcer)\n* Tumor in the colon or rectum at diagnostic imaging\n* Transfer to other hospital outside the region'}, 'identificationModule': {'nctId': 'NCT06919068', 'acronym': 'AB-care', 'briefTitle': 'Examination of the Large Intestine With Camera Capsule in Patients With Blood Stream Infection With Gut-associated Bacteria', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'Colonic Capsule Endoscopy for Screening of Neoplasms in Patients With Anaerobic Bacteremia', 'orgStudyIdInfo': {'id': 'VEK_ID_S-20240090'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Colon capsule endoscopy', 'type': 'DIAGNOSTIC_TEST', 'description': 'PillCam Colon 2'}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Odense', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Mark Bremholm Ellebæk, Professor', 'role': 'CONTACT', 'email': 'Mark.Ellebaek1@rsyd.dk', 'phone': '004540880511'}], 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'centralContacts': [{'name': 'Charlotte Nielsen Agergaard, MD', 'role': 'CONTACT', 'email': 'charlotte.agergaard@rsyd.dk', 'phone': '004565414797'}, {'name': 'Mark Bremholm Ellebæk, Professor', 'role': 'CONTACT', 'email': 'Mark.Ellebaek1@rsyd.dk', 'phone': '004540880511'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odense University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}