Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-28 @ 2:27 PM
Study NCT ID:
NCT01521650
Status:
COMPLETED
Last Update Posted:
2021-03-10
First Post:
2012-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Probiotics Against Pathogenic Bacteria in Connection With Anaesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019936', 'term': 'Probiotics'}], 'ancestors': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-08', 'studyFirstSubmitDate': '2012-01-26', 'studyFirstSubmitQcDate': '2012-01-28', 'lastUpdatePostDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences in pathogenic bacteria in the oropharynx and lower airways', 'timeFrame': 'During hospitalization, up to 4 weeks', 'description': 'Emerging and resident bacteria will be compared for the cultures taken in the oropharynx and from tracheal secretions in conection with anaestesia and a surgical intervention'}], 'secondaryOutcomes': [{'measure': 'White blood cells', 'timeFrame': 'During hospitalization, up to 4 weeks', 'description': 'WBC taken pre-op and days 1,2,3 post-op'}, {'measure': 'CRP', 'timeFrame': 'During hospitalization, up to 4 weeks', 'description': 'CRP taken pre-op and days 1,2,3 post-op'}, {'measure': 'Pneumonia', 'timeFrame': 'Up till 7 days postoperatively', 'description': 'X-ray verified infiltrations in combination with expectorates'}, {'measure': 'Length of hospital stay', 'timeFrame': 'time to discharged from hospital or patients death', 'description': 'Comparison of length of stay between the intervention group and the control group'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Probiotics', 'Anaesthesia', 'Intubation', 'Pathogenic bacteria'], 'conditions': ['Oropharyngeal Microbiology']}, 'referencesModule': {'references': [{'pmid': '10909023', 'type': 'BACKGROUND', 'citation': 'Stjernquist-Desatnik A, Warfving H, Johansson ML. Persistence of Lactobacillus plantarum DSM 9843 on human tonsillar surface after oral administration in fermented oatmeal gruel. A pilot study. Acta Otolaryngol Suppl. 2000;543:215-9. doi: 10.1080/000164800454422.'}, {'pmid': '18990201', 'type': 'BACKGROUND', 'citation': 'Klarin B, Molin G, Jeppsson B, Larsson A. Use of the probiotic Lactobacillus plantarum 299 to reduce pathogenic bacteria in the oropharynx of intubated patients: a randomised controlled open pilot study. Crit Care. 2008;12(6):R136. doi: 10.1186/cc7109. Epub 2008 Nov 6.'}]}, 'descriptionModule': {'briefSummary': 'Longer surgical procedures require intubation and there is a potential risk of contaminating the lower airways with pathogenic bacteria from the mouth and oropharynx.\n\nHealthy people seldom have pathogenic bacteria originating from the gastro-intestinal canal but those do occur among patients, both in those not so sick and patients with more severe problems.\n\nFor ICU patients we have seen a reduction of emerging enteric bacteria in patients given oral care with probiotics and this is a pilot study to explore the possibility of the same kind of positive effects in patients due for longer (more than 4 hours of anesthesia) procedures.\n\nRandomisation\n\n* No prophylaxis\n* Preparation with a probiotic suspension before intubation.\n\nCultures\n\n* oropharynx\n\n * before treatment\n * after intubation\n * before extubation\n * day 1 postoperatively\n* tracheal secretions\n\n * after intubation\n * before extubation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients\n* Planned interventions\n* Anaesthesia \\> 4 hours and requiring intubation\n\nExclusion Criteria:\n\n* Ulcers in the mouth, oropharynx, oesophagus and stomach\n* Current infections in the airways\n* Known immuno deficiences\n* Emergency cases'}, 'identificationModule': {'nctId': 'NCT01521650', 'briefTitle': 'Probiotics Against Pathogenic Bacteria in Connection With Anaesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Region Skane'}, 'officialTitle': 'Probiotics for Reduction of Colonisation With Pathogenic Bacteria in the Oropharynx in Connection With Anaesthesia', 'orgStudyIdInfo': {'id': 'ProAnest'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotics', 'description': 'Patients will gurgle and swallow a mixture of probiotic bacteria', 'interventionNames': ['Dietary Supplement: Probiotics']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No intervention. What has been the standard procedure so far'}], 'interventions': [{'name': 'Probiotics', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Lactobacillus plantarum 299', 'Lactobacillus plantarum 299v'], 'description': 'Patients will gurgle and swallow a mixture of probiotic bacteria', 'armGroupLabels': ['Probiotics']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE-22185', 'city': 'Lund', 'country': 'Sweden', 'facility': 'Lund University Hospital', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}], 'overallOfficials': [{'name': 'Bengt klarin, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lund University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Results are intended to be published in a scientific journal'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Skane', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lund University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD Consultant', 'investigatorFullName': 'Bengt Klarin', 'investigatorAffiliation': 'Region Skane'}}}}