Antiviral Activity of Oral Probiotics

Overview

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.

Full Title of Study: “Assessment of Anti-viral Activity of Saliva Obtained From Human Volunteers Following Application of Probiotic Streptococcus Salivarius to the Oral Cavity”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 23, 2022

Detailed Description

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.

Interventions

  • Dietary Supplement: 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.
  • Dietary Supplement: 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.
  • Dietary Supplement: 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.
  • Dietary Supplement: 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.

Arms, Groups and Cohorts

  • Active Comparator: Streptococcus salivarius K12
    • Streptococcus salivarius K12 (Dose 1: 1 Billion colony forming units /g)
  • Active Comparator: Streptococcus salivarius K12 with a prebiotic included
    • Streptococcus salivarius K12 (Dose 1: 1 Billion colony forming units /g)
  • Active Comparator: Streptococcus salivarius M18
    • Streptococcus salivarius M18 (Dose 1: 1 Billion colony forming units /g)
  • Active Comparator: Streptococcus salivarius M18 with a prebiotic included
    • Streptococcus salivarius M18 (Dose 1: 1 Billion colony forming units /g)

Clinical Trial Outcome Measures

Primary Measures

  • Change in antiviral activity following dosing with probiotic S. salivarius K12 in saliva from Day 0 (baseline) to 3 hours
    • Time Frame: 3 hours post intervention
    • 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
    • Time Frame: 8 hours post intervention
    • 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
    • Time Frame: 3 hours post intervention
    • 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
    • Time Frame: 8 hours post intervention
    • 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
    • Time Frame: 3 hours post intervention
    • 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
    • Time Frame: 8 hours post intervention
    • 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
    • Time Frame: 3 hours post intervention
    • 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
    • Time Frame: 8 hours post intervention
    • 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.

Participating in This Clinical Trial

Inclusion Criteria

1. In general good health 18 – 80 years of age. 2. Practice good oral hygiene. Exclusion criteria:

1. Have a history of autoimmune disease or are immunocompromised. 2. Are on concurrent antibiotic therapy or regular antibiotic use within last 1 week 3. History of allergy (e.g. dairy).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • John Hale
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: John Hale, Chief Technology Officer – BLIS Technologies Limited
  • Overall Official(s)
    • John D Hale, PhD, Study Director, Blis Technologies Ltd, Dunedin, New Zealand
    • John R Tagg, PhD, Principal Investigator, Blis Technologies Ltd, Dunedin, New Zealand
    • Liam Harold, PhD, Principal Investigator, Blis Technologies Ltd, Dunedin, New Zealand
  • Overall Contact(s)
    • John D Hale, PhD, 6434740988, john.hale@blis.co.nz

References

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. 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.

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