search
Back to results

Antiviral Activity of Oral Probiotics

Primary Purpose

Lower Respiratory Tract Infection, Upper Respiratory Tract Infection

Status
Recruiting
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
Streptococcus salivarius K12 Powder 1 Billion colony forming units /g)
Streptococcus salivarius K12 Powder (1 Billion colony forming units /g) with a prebiotic included
Streptococcus salivarius M18 Powder (1 Billion colony forming units /g)
Streptococcus salivarius M18 Powder (1 Billion colony forming units /g) with a prebiotic included
Sponsored by
John Hale
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Lower Respiratory Tract Infection focused on measuring Streptococcus salivarius K12, Probiotic, Antiviral activity, Antibacterial activity, microbial colonization, oral probiotic, powder, prebiotic

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Blis Technologies LtdRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Streptococcus salivarius K12

Streptococcus salivarius K12 with a prebiotic included

Streptococcus salivarius M18

Streptococcus salivarius M18 with a prebiotic included

Arm Description

Streptococcus salivarius K12 (Dose 1: 1 Billion colony forming units /g)

Streptococcus salivarius K12 (Dose 1: 1 Billion colony forming units /g)

Streptococcus salivarius M18 (Dose 1: 1 Billion colony forming units /g)

Streptococcus salivarius M18 (Dose 1: 1 Billion colony forming units /g)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 9, 2022
Last Updated
May 11, 2022
Sponsor
John Hale
search

1. Study Identification

Unique Protocol Identification Number
NCT05374070
Brief Title
Antiviral Activity of Oral Probiotics
Official Title
Assessment of Anti-viral Activity of Saliva Obtained From Human Volunteers Following Application of Probiotic Streptococcus Salivarius to the Oral Cavity
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2022 (Anticipated)
Primary Completion Date
June 23, 2022 (Anticipated)
Study Completion Date
August 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
John Hale

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Respiratory Tract Infection, Upper Respiratory Tract Infection
Keywords
Streptococcus salivarius K12, Probiotic, Antiviral activity, Antibacterial activity, microbial colonization, oral probiotic, powder, prebiotic

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Streptococcus salivarius K12
Arm Type
Active Comparator
Arm Description
Streptococcus salivarius K12 (Dose 1: 1 Billion colony forming units /g)
Arm Title
Streptococcus salivarius K12 with a prebiotic included
Arm Type
Active Comparator
Arm Description
Streptococcus salivarius K12 (Dose 1: 1 Billion colony forming units /g)
Arm Title
Streptococcus salivarius M18
Arm Type
Active Comparator
Arm Description
Streptococcus salivarius M18 (Dose 1: 1 Billion colony forming units /g)
Arm Title
Streptococcus salivarius M18 with a prebiotic included
Arm Type
Active Comparator
Arm Description
Streptococcus salivarius M18 (Dose 1: 1 Billion colony forming units /g)
Intervention Type
Dietary Supplement
Intervention Name(s)
Streptococcus salivarius K12 Powder 1 Billion colony forming units /g)
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Streptococcus salivarius K12 Powder (1 Billion colony forming units /g) with a prebiotic included
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Streptococcus salivarius M18 Powder (1 Billion colony forming units /g)
Intervention Description
In this study, a powder formulation will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 to the oral cavity.
Intervention Type
Dietary Supplement
Intervention Name(s)
Streptococcus salivarius M18 Powder (1 Billion colony forming units /g) with a prebiotic included
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in antiviral activity following dosing with probiotic S. salivarius K12 in saliva from Day 0 (baseline) to 3 hours
Description
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).
Time Frame
3 hours post intervention
Title
Change in antiviral activity following dosing with probiotic S. salivarius K12 in saliva from Day 0 (baseline) to 8 hours
Description
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).
Time Frame
8 hours post intervention
Title
Change in antiviral activity following dosing with probiotic S. salivarius K12 with prebiotic in saliva from Day 0 (baseline) to 3 hours
Description
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).
Time Frame
3 hours post intervention
Title
Change in antiviral activity following dosing with probiotic S. salivarius K12 with prebiotic in saliva from Day 0 (baseline) to 8 hours
Description
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)
Time Frame
8 hours post intervention
Title
Change in antiviral activity following dosing with probiotic S. salivarius M18 in saliva from Day 0 (baseline) to 3 hours
Description
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.
Time Frame
3 hours post intervention
Title
Change in antiviral activity following dosing with probiotic S. salivarius M18 in saliva from Day 0 (baseline) to 8 hours
Description
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.
Time Frame
8 hours post intervention
Title
Change in antiviral activity following dosing with probiotic S. salivarius M18 with prebiotic in saliva from Day 0 (baseline) to 3 hours
Description
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.
Time Frame
3 hours post intervention
Title
Change in antiviral activity following dosing with probiotic S. salivarius M18 with prebiotic in saliva from Day 0 (baseline) to 8 hours
Description
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.
Time Frame
8 hours post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John D Hale, PhD
Phone
6434740988
Email
john.hale@blis.co.nz
First Name & Middle Initial & Last Name or Official Title & Degree
John R Tagg, PhD
Phone
6434740988
Email
john.tagg@blis.co.nz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John D Hale, PhD
Organizational Affiliation
Blis Technologies Ltd, Dunedin, New Zealand
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
John R Tagg, PhD
Organizational Affiliation
Blis Technologies Ltd, Dunedin, New Zealand
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Liam Harold, PhD
Organizational Affiliation
Blis Technologies Ltd, Dunedin, New Zealand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Blis Technologies Ltd
City
Dunedin
State/Province
Otago
ZIP/Postal Code
9012
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John D Hale, PhD
Phone
+6434740988
Email
john.hale@blis.co.nz
First Name & Middle Initial & Last Name & Degree
Liam Harold, PhD
Phone
+6434740988
Email
liam.harold@blis.co.nz

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Study report 3 months after the completion of the study.
IPD Sharing Access Criteria
Summary study report will be shared by Principal investigator upon request if not published in public literature.
Citations:
PubMed Identifier
17194838
Citation
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.
Results Reference
background
PubMed Identifier
26781236
Citation
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.
Results Reference
background

Learn more about this trial

Antiviral Activity of Oral Probiotics

We'll reach out to this number within 24 hrs