Antiviral Activity of Oral Probiotics

NCT05374070 | Unknown

• 1 other identifier: BLTCT2022/2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Respiratory Tract Infection; Upper Respiratory Tract Infection

Keywords

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

Outcome Measures

Primary Outcomes (8)

• 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).

  3 hours post intervention

• 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).

  8 hours post intervention

• 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).

  3 hours post intervention

• 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)

  8 hours post intervention

• 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.

  3 hours post intervention

• 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.

  8 hours post intervention

• 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.

  3 hours post intervention

• 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.

  8 hours post intervention

Study Arms (4)

Streptococcus salivarius K12

ACTIVE COMPARATOR

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

Dietary Supplement: Streptococcus salivarius K12 Powder 1 Billion colony forming units /g)

Streptococcus salivarius K12 with a prebiotic included

ACTIVE COMPARATOR

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

Dietary Supplement: Streptococcus salivarius K12 Powder (1 Billion colony forming units /g) with a prebiotic included

Streptococcus salivarius M18

ACTIVE COMPARATOR

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

Dietary Supplement: Streptococcus salivarius M18 Powder (1 Billion colony forming units /g)

Streptococcus salivarius M18 with a prebiotic included

ACTIVE COMPARATOR

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

Dietary Supplement: Streptococcus salivarius M18 Powder (1 Billion colony forming units /g) with a prebiotic included

Interventions

Streptococcus salivarius K12 Powder 1 Billion colony forming units /g) DIETARY_SUPPLEMENT

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

Streptococcus salivarius K12 Powder (1 Billion colony forming units /g) with a prebiotic included DIETARY_SUPPLEMENT

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 K12 with a prebiotic included

Streptococcus salivarius M18 Powder (1 Billion colony forming units /g) DIETARY_SUPPLEMENT

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

Streptococcus salivarius M18 Powder (1 Billion colony forming units /g) with a prebiotic included DIETARY_SUPPLEMENT

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.

Streptococcus salivarius M18 with a prebiotic included

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In general good health 18 - 80 years of age.
• Practice good oral hygiene.

You may not qualify if:

• 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).

Sponsors & Collaborators

• John Hale: lead

Study Sites (1)

Blis Technologies Ltd

Dunedin, Otago, 9012, New Zealand

RECRUITING

Related Publications (2)

• 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.

  PMID: 17194838 BACKGROUND

• 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.

  PMID: 26781236 BACKGROUND

MeSH Terms

Conditions

Respiratory Tract Infections; Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• John D Hale, PhD

  Blis Technologies Ltd, Dunedin, New Zealand

  STUDY DIRECTOR

• John R Tagg, PhD

  Blis Technologies Ltd, Dunedin, New Zealand

  PRINCIPAL INVESTIGATOR

• Liam Harold, PhD

  Blis Technologies Ltd, Dunedin, New Zealand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John D Hale, PhD

CONTACT

6434740988; john.hale@blis.co.nz

John R Tagg, PhD

CONTACT

6434740988; john.tagg@blis.co.nz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Technology Officer

Model Details: 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: 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)

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 13, 2022
• Study Start: May 23, 2022
• Primary Completion: June 23, 2022
• Study Completion: August 15, 2022
• Last Updated: May 13, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Study report 3 months after the completion of the study.
• Access Criteria: Summary study report will be shared by Principal investigator upon request if not published in public literature.

Locations

NZ (1)