Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2022-05-23
2022-08-15
Brief Summary
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Detailed Description
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Participants will be randomly assigned to one of the 4 groups consuming probiotic powder containing Streptococcus salivarius K12 or S. salivarius M18 with or without prebiotics (e.g. sugars that may promote probiotic activity). Saliva samples will be collected at predetermined time points pre and post intervention. Antibacterial and Antiviral activity will be determined following established assays. Colonisation efficacy will be determined by enumerating the probiotic in the saliva samples using standard microbiological techniques.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
1. Probiotic Streptococcus salivarius K12 Powder (Dose: 1 Billion cfu/g)
2. Probiotic Streptococcus salivarius K12 Powder with prebiotic (Dose: 1 Billion cfu/g)
3. Probiotic Streptococcus salivarius M18 Powder (Dose: 1 Billion cfu/g)
4. Probiotic Streptococcus salivarius M18 Powder with prebiotic (Dose: 1 Billion cfu/g)
BASIC_SCIENCE
NONE
Study Groups
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Streptococcus salivarius K12
Streptococcus salivarius K12 (Dose 1: 1 Billion colony forming units /g)
Streptococcus salivarius K12 Powder 1 Billion colony forming units /g)
Probiotic Streptococcus salivarius K12 products are commercially available in traditional formats such as lozenges for local delivery in the oral cavity to provide oral health benefits. In this study, a powder formulation will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity.
Streptococcus salivarius K12 with a prebiotic included
Streptococcus salivarius K12 (Dose 1: 1 Billion colony forming units /g)
Streptococcus salivarius K12 Powder (1 Billion colony forming units /g) with a prebiotic included
In this study, a powder formulation containing Streptococcus salivarius K12 and a prebiotic will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity.
Streptococcus salivarius M18
Streptococcus salivarius M18 (Dose 1: 1 Billion colony forming units /g)
Streptococcus salivarius M18 Powder (1 Billion colony forming units /g)
In this study, a powder formulation will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 to the oral cavity.
Streptococcus salivarius M18 with a prebiotic included
Streptococcus salivarius M18 (Dose 1: 1 Billion colony forming units /g)
Streptococcus salivarius M18 Powder (1 Billion colony forming units /g) with a prebiotic included
In this study, a powder formulation containing S. salivarius M18 and a prebiotic will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 to the oral cavity.
Interventions
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Streptococcus salivarius K12 Powder 1 Billion colony forming units /g)
Probiotic Streptococcus salivarius K12 products are commercially available in traditional formats such as lozenges for local delivery in the oral cavity to provide oral health benefits. In this study, a powder formulation will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity.
Streptococcus salivarius K12 Powder (1 Billion colony forming units /g) with a prebiotic included
In this study, a powder formulation containing Streptococcus salivarius K12 and a prebiotic will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity.
Streptococcus salivarius M18 Powder (1 Billion colony forming units /g)
In this study, a powder formulation will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 to the oral cavity.
Streptococcus salivarius M18 Powder (1 Billion colony forming units /g) with a prebiotic included
In this study, a powder formulation containing S. salivarius M18 and a prebiotic will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 to the oral cavity.
Eligibility Criteria
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Inclusion Criteria
2. Practice good oral hygiene.
Exclusion Criteria
2. Are on concurrent antibiotic therapy or regular antibiotic use within last 1 week
3. History of allergy (e.g. dairy).
18 Years
80 Years
ALL
Yes
Sponsors
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John Hale
INDUSTRY
Responsible Party
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John Hale
Chief Technology Officer
Principal Investigators
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John D Hale, PhD
Role: STUDY_DIRECTOR
Blis Technologies Ltd, Dunedin, New Zealand
John R Tagg, PhD
Role: PRINCIPAL_INVESTIGATOR
Blis Technologies Ltd, Dunedin, New Zealand
Liam Harold, PhD
Role: PRINCIPAL_INVESTIGATOR
Blis Technologies Ltd, Dunedin, New Zealand
Locations
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Blis Technologies Ltd
Dunedin, Otago, New Zealand
Countries
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Central Contacts
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Facility Contacts
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References
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Hyink O, Wescombe PA, Upton M, Ragland N, Burton JP, Tagg JR. Salivaricin A2 and the novel lantibiotic salivaricin B are encoded at adjacent loci on a 190-kilobase transmissible megaplasmid in the oral probiotic strain Streptococcus salivarius K12. Appl Environ Microbiol. 2007 Feb;73(4):1107-13. doi: 10.1128/AEM.02265-06. Epub 2006 Dec 28.
Burton JP, Chilcott CN, Wescombe PA, Tagg JR. Extended Safety Data for the Oral Cavity Probiotic Streptococcus salivarius K12. Probiotics Antimicrob Proteins. 2010 Oct;2(3):135-44. doi: 10.1007/s12602-010-9045-4.
Other Identifiers
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BLTCT2022/2
Identifier Type: -
Identifier Source: org_study_id
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