Antiviral Activity of Oral Probiotics

Assessment of Anti-viral Activity of Saliva Obtained From Human Volunteers Following Application of Probiotic Streptococcus Salivarius to the Oral Cavity

The aim of this study is to test saliva samples obtained from healthy human participants for anti-viral activity after they have consumed S. salivarius probiotic in a powder format.

This is a randomized controlled open pilot study to evaluate saliva samples collected from participants following their consumption of powders containing the commercially marketed probiotic bacterium S. salivarius K12 or S. salivarius M18. 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.

Streptococcus salivarius K12, Probiotic, Antiviral activity, Antibacterial activity, microbial colonization, oral probiotic, powder, prebiotic

Participants will be randomly assigned to one of the 4 groups consuming powder containing Streptococcus salivarius K12 or S. salivarius M18 with or without prebiotic: Probiotic Streptococcus salivarius K12 Powder (Dose: 1 Billion cfu/g) Probiotic Streptococcus salivarius K12 Powder with prebiotic (Dose: 1 Billion cfu/g) Probiotic Streptococcus salivarius M18 Powder (Dose: 1 Billion cfu/g) Probiotic Streptococcus salivarius M18 Powder with prebiotic (Dose: 1 Billion cfu/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.

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.

In this study, a powder formulation will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 to the oral cavity.

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.

Change in antiviral activity following dosing with probiotic S. salivarius K12 in saliva from Day 0 (baseline) to 3 hours

Study will determine the antiviral activity of Streptococcus salivarius K12 without prebiotic in a powder format. The antiviral and antibacterial activity in the saliva will be determined using appropriate assays and Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data for different days (pre and post time points) and 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).

Change in antiviral activity following dosing with probiotic S. salivarius K12 in saliva from Day 0 (baseline) to 8 hours

Study will determine the antiviral activity of Streptococcus salivarius K12 without prebiotic in a powder format. The antiviral and antibacterial activity in the saliva will be determined using appropriate assays and Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data for different days (pre and post time points) and 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).

Change in antiviral activity following dosing with probiotic S. salivarius K12 with prebiotic in saliva from Day 0 (baseline) to 3 hours

Study will determine the antiviral activity of Streptococcus salivarius K12 with prebiotic in a powder format. The antiviral and antibacterial activity in the saliva will be determined using appropriate assays and Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data for different days (pre and post time points) and 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).

Change in antiviral activity following dosing with probiotic S. salivarius K12 with prebiotic in saliva from Day 0 (baseline) to 8 hours

Study will determine the antiviral activity of Streptococcus salivarius K12 with prebiotic in a powder format. The antiviral and antibacterial activity in the saliva will be determined using appropriate assays and Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data for different days (pre and post time points) and 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)

Change in antiviral activity following dosing with probiotic S. salivarius M18 in saliva from Day 0 (baseline) to 3 hours

Study will determine the antibacterial activity of Streptococcus salivarius M18 without prebiotic in a powder format. The antibacterial activity in the saliva will be determined using appropriate assays and Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data for different days (pre and post time points) and different formulations with the level of significance of p≤0.05.

Change in antiviral activity following dosing with probiotic S. salivarius M18 in saliva from Day 0 (baseline) to 8 hours

Study will determine the antibacterial activity of Streptococcus salivarius M18 without prebiotic in a powder format. The antibacterial activity in the saliva will be determined using appropriate assays and Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data for different days (pre and post time points) and different formulations with the level of significance of p≤0.05.

Change in antiviral activity following dosing with probiotic S. salivarius M18 with prebiotic in saliva from Day 0 (baseline) to 3 hours

Study will determine the antibacterial activity of Streptococcus salivarius M18 with prebiotic in a powder format. The antibacterial activity in the saliva will be determined using appropriate assays and Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data for different days (pre and post time points) and different formulations with the level of significance of p≤0.05.

Change in antiviral activity following dosing with probiotic S. salivarius M18 with prebiotic in saliva from Day 0 (baseline) to 8 hours

Study will determine the antibacterial activity of Streptococcus salivarius M18 with prebiotic in a powder format. The antibacterial activity in the saliva will be determined using appropriate assays and Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data for different days (pre and post time points) and different formulations with the level of significance of p≤0.05.

Inclusion criteria: In general good health 18 - 80 years of age. Practice good oral hygiene. Exclusion criteria: Have a history of autoimmune disease or are immunocompromised. Are on concurrent antibiotic therapy or regular antibiotic use within last 1 week History of allergy (e.g. dairy).

Data information and information included in the protocol and the Clinical study report will be shared to other researchers and/or in publications in due course.

Summary study report will be shared by Principal investigator upon request if not published in public literature.

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.