Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT05480020
Status:
UNKNOWN
Last Update Posted:
2022-07-29
First Post:
2022-07-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Probiotic Toothpaste for Microbial Colonization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003141', 'term': 'Communicable Diseases'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'A staff member not part of the study group will be assigned to distribute blinded samples. The participant or the investigators will not be aware of the dose groups.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly assigned to one of the 3 groups for brushing teeth with a probiotic toothpaste containing different doses of Streptococcus salivarius M18 Study Group A: BLIS M18 Toothpaste (1 Million Cfu/dose) (n = 10) Study Group B: BLIS M18 Toothpaste (10 Million Cfu/dose) (n = 10) Study Group C: BLIS M18 Toothpaste (100 Million Cfu/dose) (n = 10)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-28', 'studyFirstSubmitDate': '2022-07-27', 'studyFirstSubmitQcDate': '2022-07-28', 'lastUpdatePostDateStruct': {'date': '2022-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Microbial colonization from baseline (Day 0) to 1 hour', 'timeFrame': '1 hour post intervention', 'description': 'Study will determine the change in the microbial colonization efficacy of three different doses of S. salivarius M18 in a toothpaste format.\n\nStudy will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 in a toothpaste format. The saliva Statistical analysis (e.g. ANOVA) will be carried out to compare the participants data from baseline to one hour after later across three different formulations with the level of significance of p≤0.05.Overall colonization based on percentage of population colonized for different interventions will also be analyzed average and standard deviation functions using appropriate statistical analysis software (e.g. Microsoft Excel, GraphPad Prism).'}, {'measure': 'Change in Microbial colonization from baseline (Day 0) to 8 hours', 'timeFrame': '8 hours post intervention', 'description': 'Study will determine the change in the microbial colonization efficacy of three different doses of S. salivarius M18 in a toothpaste format.\n\nStudy will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 in a toothpaste format. The saliva Statistical analysis (e.g. ANOVA) will be carried out to compare the participants data from baseline to one hour after later across three different formulations with the level of significance of p≤0.05.Overall colonization based on percentage of population colonized for different interventions will also be analyzed average and standard deviation functions using appropriate statistical analysis software (e.g. Microsoft Excel, GraphPad Prism).'}, {'measure': 'Change in Microbial colonization from baseline (Day 0) to 24 hours', 'timeFrame': '24 hours post intervention', 'description': 'Study will determine the change in the microbial colonization efficacy of three different doses of S. salivarius M18 in a toothpaste format.\n\nStudy will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 in a toothpaste format. The saliva Statistical analysis (e.g. ANOVA) will be carried out to compare the participants data from baseline to one hour after later across three different formulations with the level of significance of p≤0.05.Overall colonization based on percentage of population colonized for different interventions will also be analyzed average and standard deviation functions using appropriate statistical analysis software (e.g. Microsoft Excel, GraphPad Prism).'}, {'measure': 'Change in Microbial colonization from baseline (Day 0) to 24 hours post last dose', 'timeFrame': '24 hours after last dose following 7 days of daily brushing with probiotic toothpaste.', 'description': 'Study will determine the change in the microbial colonization efficacy of three different doses of S. salivarius M18 in a toothpaste format.\n\nStudy will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 in a toothpaste format. The saliva Statistical analysis (e.g. ANOVA) will be carried out to compare the participants data from baseline to one hour after later across three different formulations with the level of significance of p≤0.05.Overall colonization based on percentage of population colonized for different interventions will also be analyzed average and standard deviation functions using appropriate statistical analysis software (e.g. Microsoft Excel, GraphPad Prism).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Probiotic toothpaste, Streptococcus salivarius M18, microbial colonization, oral probiotic, toothpaste'], 'conditions': ['Microbial Colonization']}, 'referencesModule': {'references': [{'pmid': '26491371', 'type': 'BACKGROUND', 'citation': 'Di Pierro F, Zanvit A, Nobili P, Risso P, Fornaini C. Cariogram outcome after 90 days of oral treatment with Streptococcus salivarius M18 in children at high risk for dental caries: results of a randomized, controlled study. Clin Cosmet Investig Dent. 2015 Oct 3;7:107-13. doi: 10.2147/CCIDE.S93066. eCollection 2015.'}, {'pmid': '32099975', 'type': 'BACKGROUND', 'citation': 'Bardellini E, Amadori F, Gobbi E, Ferri A, Conti G, Majorana A. Does Streptococcus Salivarius Strain M18 Assumption Make Black Stains Disappear in Children? Oral Health Prev Dent. 2020 Apr 3;18(2):161-164. doi: 10.3290/j.ohpd.a43359.'}, {'pmid': '23785463', 'type': 'BACKGROUND', 'citation': 'Burton JP, Wescombe PA, Macklaim JM, Chai MH, Macdonald K, Hale JD, Tagg J, Reid G, Gloor GB, Cadieux PA. Persistence of the oral probiotic Streptococcus salivarius M18 is dose dependent and megaplasmid transfer can augment their bacteriocin production and adhesion characteristics. PLoS One. 2013 Jun 13;8(6):e65991. doi: 10.1371/journal.pone.0065991. Print 2013.'}, {'pmid': '23449874', 'type': 'BACKGROUND', 'citation': 'Burton JP, Drummond BK, Chilcott CN, Tagg JR, Thomson WM, Hale JDF, Wescombe PA. Influence of the probiotic Streptococcus salivarius strain M18 on indices of dental health in children: a randomized double-blind, placebo-controlled trial. J Med Microbiol. 2013 Jun;62(Pt 6):875-884. doi: 10.1099/jmm.0.056663-0. Epub 2013 Feb 28.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the colonization efficacy of probiotic toothpastes in healthy adults', 'detailedDescription': 'This is a double blind randomized controlled study with no cross over to evaluate the colonization efficacy of toothpaste containing a commercially available probiotic bacterium Streptococcus salivarius M18.\n\nParticipants will be randomly assigned to one of the 3 groups for brushing teeth with a probiotic toothpaste containing different doses of Streptococcus salivarius M18 over a seven day period. Saliva samples will be collected at predetermined time points pre and post intervention. Colonization efficacy will be determined by enumerating the probiotic in the saliva samples using standard microbiological techniques.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* In general good health\n* Practise good oral hygiene\n\nExclusion Criteria:\n\n1. Have a history of autoimmune disease or are immunocompromised.\n2. Are on concurrent antibiotic therapy or regular antibiotic use within last 1 week\n3. History of allergy (e.g. dairy).'}, 'identificationModule': {'nctId': 'NCT05480020', 'briefTitle': 'Probiotic Toothpaste for Microbial Colonization', 'organization': {'class': 'INDUSTRY', 'fullName': 'BLIS Technologies Limited'}, 'officialTitle': 'Colonisation Efficacy of Streptococcus Salivarius M18 Toothpaste', 'orgStudyIdInfo': {'id': 'BLTCT2022/5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Streptococcus salivarius M18 toothpaste dose 1', 'description': 'Streptococcus salivarius M18 toothpaste containing 1 million cfu/g', 'interventionNames': ['Other: Streptococcus salivarius M18 toothpaste']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Streptococcus salivarius M18 toothpaste dose 2', 'description': 'Streptococcus salivarius M18 toothpaste containing 10 million cfu/g', 'interventionNames': ['Other: Streptococcus salivarius M18 toothpaste']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Streptococcus salivarius M18 toothpaste dose 3', 'description': 'Streptococcus salivarius M18 toothpaste containing 100 million cfu/g', 'interventionNames': ['Other: Streptococcus salivarius M18 toothpaste']}], 'interventions': [{'name': 'Streptococcus salivarius M18 toothpaste', 'type': 'OTHER', 'description': 'Probiotics Streptococcus salivarius M18 toothpaste 1 million cfu/g\n\nIn this study, a toothpaste formulation containing S. salivarius M18 will be evaluated for its potential for delivering the probiotic to the oral cavity.', 'armGroupLabels': ['Streptococcus salivarius M18 toothpaste dose 1']}, {'name': 'Streptococcus salivarius M18 toothpaste', 'type': 'OTHER', 'description': 'Probiotics Streptococcus salivarius M18 toothpaste 10 million cfu/g\n\nIn this study, a toothpaste formulation containing S. salivarius M18 will be evaluated for its potential for delivering the probiotic to the oral cavity.', 'armGroupLabels': ['Streptococcus salivarius M18 toothpaste dose 2']}, {'name': 'Streptococcus salivarius M18 toothpaste', 'type': 'OTHER', 'description': 'Probiotics Streptococcus salivarius M18 toothpaste 100 million cfu/g\n\nIn this study, a toothpaste formulation containing S. salivarius M18 will be evaluated for its potential for delivering the probiotic to the oral cavity.', 'armGroupLabels': ['Streptococcus salivarius M18 toothpaste dose 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9012', 'city': 'Dunedin', 'state': 'Otago', 'status': 'RECRUITING', 'country': 'New Zealand', 'contacts': [{'name': 'John D Hale, PhD', 'role': 'CONTACT', 'email': 'john.hale@blis.co.nz', 'phone': '+6434740988'}], 'facility': 'Blis Technologies Ltd', 'geoPoint': {'lat': -45.87416, 'lon': 170.50361}}], 'centralContacts': [{'name': 'John D Hale, PhD', 'role': 'CONTACT', 'email': 'john.hale@blis.co.nz', 'phone': '+6434740988'}, {'name': 'Rohit Jain, PhD', 'role': 'CONTACT', 'email': 'rohit.jain@blis.co.nz', 'phone': '+6434740988'}], 'overallOfficials': [{'name': 'John R Tagg, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Blis Technologies'}, {'name': 'Rohit Jain, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Blis Technologies'}, {'name': 'John D Hale, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Blis Technologies'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'John Hale', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'CTO', 'investigatorFullName': 'John Hale', 'investigatorAffiliation': 'BLIS Technologies Limited'}}}}