Ignite Creation Date:
2025-12-24 @ 12:03 PM
Ignite Modification Date:
2025-12-27 @ 10:32 PM
Study NCT ID:
NCT00695461
Status:
COMPLETED
Last Update Posted:
2008-06-11
First Post:
2008-06-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lactobacillus Plantarum 299v in Colon Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D006965', 'term': 'Hyperplasia'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-06', 'completionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-06-10', 'studyFirstSubmitDate': '2008-06-09', 'studyFirstSubmitQcDate': '2008-06-10', 'lastUpdatePostDateStruct': {'date': '2008-06-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in intestinal bacterial microflora', 'timeFrame': 'Before inclusion, after treatment, during surgery, postoperative day 6, 6 weeks, 6 months'}], 'secondaryOutcomes': [{'measure': 'Bacterial translocation', 'timeFrame': 'During surgery'}, {'measure': 'Inflammatory response (cytokines)', 'timeFrame': 'Preoperative, during operation, 3, 24 an 48 hours postoperastive'}, {'measure': 'Cell proliferation', 'timeFrame': 'During surgery'}, {'measure': 'Postoperative complications', 'timeFrame': 'One week after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Colorectal surgery', 'Probiotics', 'Lactobacillus', 'Bacterial translocation', 'Postoperative complications', 'Inflammatory reaction'], 'conditions': ['Bacterial Translocation', 'Inflammation', 'Cell Proliferation']}, 'descriptionModule': {'briefSummary': 'Intestinal pathogenes are often involved in postoperative complications after colon surgery. Probiotic bacteria, i e live bacteria which have beneficial effects on the host when ingested, have been shown to reduce bacterial translocation in animal studies. However, in humans studies results have varied. The purpose with this study was to find whether high doses of Lactobacillus plantarum 299v affects the potentially pathogenic microflora of the gut, bacterial translocation and cell proliferation in patients undergoing planned colon surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* planned resection of colon for malignant or benign disease\n* all ages\n\nExclusion Criteria:\n\n* unable to understand instructions and perform preoperative intake of study preparation\n* rectal surgery\n* present or past history of endocarditis\n* congenital or acquired valvular heart disease'}, 'identificationModule': {'nctId': 'NCT00695461', 'acronym': 'Lp 299v', 'briefTitle': 'Lactobacillus Plantarum 299v in Colon Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Skane University Hospital'}, 'officialTitle': 'L Plantarum 299v to Patients Undergoing Colon Resection - a Randomized Placebo-Controlled Study', 'orgStudyIdInfo': {'id': 'PRO NAT 004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Receives Lactobacillus plantarum 299v in an oatmeal drink, at a concentration of 10(9) colony-forming-units/ml, 100 ml per day, starting one week before surgery, finishing 5 days after surgery.', 'interventionNames': ['Dietary Supplement: Lactobacillus plantarum 299v in oatmeal drink']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Receives oatmeal drink, 100 ml per day, starting one week before surgery, finishing 5 days after surgery.', 'interventionNames': ['Dietary Supplement: Oatmeal drink']}], 'interventions': [{'name': 'Lactobacillus plantarum 299v in oatmeal drink', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Bacteria in a concentration of 10(9) CFU/ml', 'armGroupLabels': ['1']}, {'name': 'Oatmeal drink', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oatmeal drink as in arm 1 but without bacteria added.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S-20502', 'city': 'Malmo', 'country': 'Sweden', 'facility': 'Dept of Surgery, Malmö University Hospital', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}], 'overallOfficials': [{'name': 'Peter Mangell, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept of Surgery, Malmö University Hospital, Malmö, Sweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Skane University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Peter Mangell, MD', 'oldOrganization': 'Dept of Surgery, Malmö University Hospital'}}}}