Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-25 @ 2:11 PM
Study NCT ID:
NCT01730066
Status:
COMPLETED
Last Update Posted:
2020-10-12
First Post:
2012-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Probiotics Against Pathogenic Bacteria in Advanced ENT-Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C008315', 'term': 'maltodextrin'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-08', 'studyFirstSubmitDate': '2012-11-08', 'studyFirstSubmitQcDate': '2012-11-14', 'lastUpdatePostDateStruct': {'date': '2020-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences in pathogenic bacteria in the oropharynx', 'timeFrame': 'During hospitalization, anticipated mean time 12 days', 'description': 'Emerging and resident bacteria will be compared for the cultures taken in the oropharynx and from tracheal secretions in connection to a surgical intervention and postoperatively'}], 'secondaryOutcomes': [{'measure': 'White Blood Cell count', 'timeFrame': 'During hospital stay, expected mean LOS 12 days', 'description': 'WBC taken pre-op and then on predefined days postoperatively'}, {'measure': 'C Reactive Protein', 'timeFrame': 'Throughout the hospital stay, expected mean LOS 12 days', 'description': 'CRP taken pre-op and then on predefined days postoperatively'}, {'measure': 'Length of Hospital stay', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 2-3 weeks', 'description': 'Length of stay is recorded for the Hospital stay, and for those cases that have an extended post-operative period in the ICU, the length of the ICU stay will be recorded'}, {'measure': 'Survival', 'timeFrame': 'Six months', 'description': 'For participating patients the status of survival or non survival at days 28 and 180 (six months) will be recorded'}, {'measure': 'Diarrhoea and obstipation', 'timeFrame': 'Throughout the hospital stay, expected mean LOS 12 days', 'description': 'As ICU patients tend to display diarrhoea as well as obstipation the frequency and consistency of stools will be recorded.\n\nProbiotics are anticipated to stabilise bowel function'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Probiotics', 'Pathogenic enteric bacteria', 'Oropharyngeal flora', 'CRP', 'WBC'], 'conditions': ['Advanced ENT Surgery', 'Microbiological Flora in the Oropharynx and Lower Airways']}, '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.'}], 'seeAlsoLinks': [{'url': 'http://www.probi.se', 'label': 'Provider of study product'}]}, 'descriptionModule': {'briefSummary': 'Surgery in the mouth and oropharynx is performed in an area colonised by bacteria non-pathogenic and pathogenic.\n\nAntibiotics are used regularly resulting in disturbances in the intestinal microbiological flora and consequently diarrhoea that can be troublesome. The use of antibiotics throughout the hospital stay for these difficult cases represent a risk of development of resistant strains.\n\nMost of the patients have cancer diagnoses and have radiation therapy before surgery. This increases the risk of the patients having pathogenic bacteria normally present in the lower GI-tract.\n\nThe investigators have shown for ICU patients that treatment with probiotics reduces the number of emerging enteral bacteria in the oropharynx and now the investigators will perform an adjusted procedure for patients planned for large ear, nose, and throat (ENT) surgery.\n\nPatients will preoperatively gurgle a suspension of probiotics and then swallow the preparation.\n\nPostoperatively the probiotics is given enterally and a eventually by mouth again.\n\nCultures will be taken from the oropharynx and tracheal secretions and the results will be compared', 'detailedDescription': '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\nSurgery including the mouth and the oropharynx is performed in an area that is colonised by hundreds of different bacterial species. In the healthy person there is a balance between the different microbes and possible pathogens are kept under control.\n\nPatients that are subject to surgery in the mouth, oropharynx or neck area, most often have cancer diagnoses. Preoperative treatment (mostly radiation) is done in most cases resulting in a changed spectrum of bacteria in the mouth and oropharynx. Due to lowered appetite increased difficulties to eat, in combination with cancer diagnosis, there is also a change in cranial direction of the microbiological gut flora resulting in the presence of pathogens such as Gram-negative bacteria. Those species may result in troublesome infections in the postoperative period.\n\nWith healthy people pathogenic bacteria originating from the gastro/intestinal canal are seldom found in the oropharynx, but those do occur among many patients.\n\nAntibiotics are used prophylactic and for more extensive surgery, as micro vascular procedures with free transplants of tissues, antibiotics are kept throughout the length of stay (LOS) in hospital. This results in an increased risk for the development of resistant bacteria and does result in changes in the GI flora in those patients. Diarrhoea occurs frequently and are troublesome for the patients For ICU patients we have seen a reduction of emerging enteric bacteria in patients given oral care with probiotics and this study will explore the possibility of the same kind of positive effects in patients due for extensive surgery performed during several hours.\n\nMany of the patients will have a tracheostomy performed as part of the surgical procedure.\n\nPatients will be randomised (1:1) to either no prophylaxis (standard procedure today) or to preparation with a probiotic suspension fro the day before surgery until discharge from hospital.\n\nPreoperatively the patients will gurgle a suspension of probiotics and then swallow the preparation.\n\nPostoperatively the probiotics is given enterally and a eventually when the responsible surgeon find it suitable by mouth again.\n\nCultures at inclusion, after intubation, and then on predefined days postoperatively to compare bacterial flora in the oropharynx and in tracheal secretions.\n\nInfectious parameters will be followed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective advanced and extensive ENT surgery\n* Adult patients (≥ 18 years)\n* Surgery requires general anesthesia and endotracheal intubation\n* Length of anesthesia ≥ 1,5 hours\n* Signed informed consent\n\nExclusion Criteria:\n\n* Ongoing treatment requiring infection in the lower respiratory tract\n* Chronic lung disease requiring oxygen treatment\n* Known immune deficiency'}, 'identificationModule': {'nctId': 'NCT01730066', 'briefTitle': 'Probiotics Against Pathogenic Bacteria in Advanced ENT-Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Region Skane'}, 'officialTitle': 'Probiotics for Reduction of Pathogenic Bacteria in Connection With Advanced Surgery in the Mouth, the Oropharynx, and on the Neck', 'orgStudyIdInfo': {'id': 'ProOncENT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotics', 'description': 'Patients will gurgle and swallow a mixture of probiotic bacteria preoperatively and given the same study product enterally postoperatively', 'interventionNames': ['Dietary Supplement: L. plantarum 299 and L. plantarum 299v (+maltodextrin)']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No intervention.What has been the standard procedure so far'}], 'interventions': [{'name': 'L. plantarum 299 and L. plantarum 299v (+maltodextrin)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Patients will be given a mixture of maltodextrin ( a starch product often used i alimentary products) and two strains of probiotic bacteria ( L. plantarum 299 and L. plantarum 299v ) dissolved in water. They will gurgle and swallow the suspension from the day before surgery. Postoperatively they will be given the probiotic mixture via a nasogastric tubing twice a day and when the responsible surgeon find it suitable also orally as described above. When they can swallow no study product is given through the nasogastric tube.\n\nPatients randomized 1:1 between groups', '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 Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Results will be published in a scientific journal'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Skane', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lund University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}