Microbial Colonization of Oral Probiotics

NCT05375383 | Unknown

• 1 other identifier: BLTCT2022/3
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the colonization efficacy of probiotic lozenges and powders containing specific prebiotics in healthy adults

Conditions

Microbial Colonization

Keywords

Streptococcus salivarius K12; Probiotic; microbial colonization; oral probiotic; lozenges; powder; prebiotic; Streptococcus salivarius M18

Outcome Measures

Primary Outcomes (12)

• Change in microbial colonization from baseline (Day 0) to 1 hour for S. salivarius K12 lozenges

  Study will determine the change in microbial colonization efficacy of Streptococcus salivarius K12 with or without prebiotics from a lozenge format. The statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to one hour after later across 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).

  1 hour

• Change in microbial colonization from baseline (Day 0) to 8 hours or S. salivarius K12 lozenges

  Study will determine the change in microbial colonization efficacy of Streptococcus salivarius K12 with or without prebiotics from a lozenge format. The statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to eight hours after later across 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 hour

• Change in microbial colonization from baseline (Day 0) to 24 hours or S. salivarius K12 lozenges

  Study will determine the change in microbial colonization efficacy of Streptococcus salivarius K12 with or without prebiotics from a lozenge format. The statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to 24 hours after later across 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).

  24 hour

• Change in microbial colonization from baseline (Day 0) to 48 hours or S. salivarius K12 lozenges

  Study will determine the change in microbial colonization efficacy of Streptococcus salivarius K12 with or without prebiotics from a lozenge format. The statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to 48hours after later across 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).

  48 hour

• in microbial colonization from baseline (Day 0) to 1 hour for S. salivarius K12 powder format

  Study will determine the change in microbial colonization efficacy of Streptococcus salivarius K12 with or without prebiotics from a powder format. The statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to one hour after later across two 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).

  1 hour

• in microbial colonization from baseline (Day 0) to 8 hour for S. salivarius K12 powder format

  Study will determine the change in microbial colonization efficacy of Streptococcus salivarius K12 with or without prebiotics from a powder format. The statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to 8 hours after later across two 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

• in microbial colonization from baseline (Day 0) to 24 hours for S. salivarius K12 powder format

  Study will determine the change in microbial colonization efficacy of Streptococcus salivarius K12 with or without prebiotics from a powder format. The statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to 24 hours after later across two 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).

  24 hours

• in microbial colonization from baseline (Day 0) to 48 hours for S. salivarius K12 powder format

  Study will determine the change in microbial colonization efficacy of Streptococcus salivarius K12 with or without prebiotics from a powder format. The statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to 48 hours after later across two 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).

  48 hours

• Change in microbial colonization from baseline (Day 0) to 1 hour for S. salivarius M18 lozenges

  Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 with or without prebiotics from a lozenge format. The statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to one hour after later across 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).

  1 hour

• Change in microbial colonization from baseline (Day 0) to 8 hours for S. salivarius M18 lozenges

  Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 with or without prebiotics from a lozenge format. The statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to 8 hour after later across 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 hour

• Change in microbial colonization from baseline (Day 0) to 24 hours for S. salivarius M18 lozenges

  Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 with or without prebiotics from a lozenge format. The statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to 24 hour after later across 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).

  24 hour

• Change in microbial colonization from baseline (Day 0) to 48 hours for S. salivarius M18 lozenges

  Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 with or without prebiotics from a lozenge format. The statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to 48 hour after later across 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).

  48 hour

Study Arms (12)

Streptococcus salivarius K12 lozenge

ACTIVE COMPARATOR

Streptococcus salivarius K12 lozenge

Dietary Supplement: Streptococcus salivarius K12 lozenge

Probiotic S. salivarius K12 lozenges containing prebiotic A

ACTIVE COMPARATOR

Streptococcus salivarius K12 lozenge with prebiotic

Dietary Supplement: Probiotic S. salivarius K12 lozenges containing prebiotic A

Probiotic S. salivarius K12 lozenges containing prebiotic B

ACTIVE COMPARATOR

Streptococcus salivarius K12 lozenge with prebiotic

Dietary Supplement: Probiotic S. salivarius K12 lozenges containing prebiotic B

Probiotic S. salivarius K12 lozenges containing prebiotic A and B

ACTIVE COMPARATOR

Streptococcus salivarius K12

Dietary Supplement: Probiotic S. salivarius K12 lozenges containing prebiotics A and B

Probiotic S. salivarius K12 powder

ACTIVE COMPARATOR

Streptococcus salivarius K12 powder

Dietary Supplement: Probiotic S. salivarius K12 powder

Probiotic S. salivarius K12 powder containing prebiotic A

ACTIVE COMPARATOR

Streptococcus salivarius K12 powder with prebiotic

Dietary Supplement: Probiotic S. salivarius K12 powder containing prebiotic A

Probiotic S. salivarius K12 powder containing prebiotic B

ACTIVE COMPARATOR

Streptococcus salivarius K12 powder with prebiotic

Dietary Supplement: Probiotic S. salivarius K12 powder containing prebiotic B

Probiotic S. salivarius K12 powder containing prebiotic A and B

ACTIVE COMPARATOR

Streptococcus salivarius K12 powder with prebiotic

Dietary Supplement: Probiotic S. salivarius K12 powder containing prebiotics A and B

Probiotic S. salivarius M18 lozenges

ACTIVE COMPARATOR

Streptococcus salivarius M18 lozenge

Dietary Supplement: Probiotic S. salivarius M18 lozenges

Probiotic S. salivarius M18 lozenges containing prebiotic A

ACTIVE COMPARATOR

Streptococcus salivarius M18 lozenge with prebiotic

Dietary Supplement: Probiotic S. salivarius M18 lozenges containing prebiotic A

Probiotic S. salivarius M18 lozenges der containing prebiotic B

ACTIVE COMPARATOR

Streptococcus salivarius M18 lozenge with prebiotic

Dietary Supplement: Probiotic S. salivarius M18 lozenges containing prebiotic B

Probiotic S. salivarius M18 + lozenges containing prebiotic A and B

ACTIVE COMPARATOR

Streptococcus salivarius M18 lozenge with prebiotic

Dietary Supplement: Probiotic S. salivarius M18 + lozenges containing prebiotic A and B

Interventions

Streptococcus salivarius K12 lozenge DIETARY_SUPPLEMENT

In this study, a lozenge will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity.

Streptococcus salivarius K12 lozenge

Probiotic S. salivarius K12 lozenges containing prebiotic A DIETARY_SUPPLEMENT

In this study, a lozenge containing a prebiotic will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity.

Probiotic S. salivarius K12 lozenges containing prebiotic A

Probiotic S. salivarius K12 lozenges containing prebiotic B DIETARY_SUPPLEMENT

In this study, a lozenge containing a prebiotic will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity.

Probiotic S. salivarius K12 lozenges containing prebiotic B

Probiotic S. salivarius K12 lozenges containing prebiotics A and B DIETARY_SUPPLEMENT

In this study, a lozenge containing two prebiotics will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity.

Probiotic S. salivarius K12 lozenges containing prebiotic A and B

Probiotic S. salivarius K12 powder DIETARY_SUPPLEMENT

In this study, a powder will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity

Probiotic S. salivarius K12 powder

Probiotic S. salivarius K12 powder containing prebiotic A DIETARY_SUPPLEMENT

In this study, a powder containing a prebiotic will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity

Probiotic S. salivarius K12 powder containing prebiotic A

Probiotic S. salivarius K12 powder containing prebiotic B DIETARY_SUPPLEMENT

In this study, a powder containing a prebiotic will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity

Probiotic S. salivarius K12 powder containing prebiotic B

Probiotic S. salivarius K12 powder containing prebiotics A and B DIETARY_SUPPLEMENT

In this study, a powder containing two prebiotics will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity

Probiotic S. salivarius K12 powder containing prebiotic A and B

Probiotic S. salivarius M18 lozenges DIETARY_SUPPLEMENT

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

Probiotic S. salivarius M18 lozenges

Probiotic S. salivarius M18 lozenges containing prebiotic A DIETARY_SUPPLEMENT

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

Probiotic S. salivarius M18 lozenges containing prebiotic A

Probiotic S. salivarius M18 lozenges containing prebiotic B DIETARY_SUPPLEMENT

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

Probiotic S. salivarius M18 lozenges der containing prebiotic B

Probiotic S. salivarius M18 + lozenges containing prebiotic A and B DIETARY_SUPPLEMENT

In this study, a lozenge containing two prebiotics will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 to the oral cavity.

Probiotic S. salivarius M18 + lozenges containing prebiotic A and B

Eligibility Criteria

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

You may qualify if:

• Male or Female 18y - 80y age
• 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

• BLIS Technologies Limited: lead

Study Sites (1)

Blis Technologies Ltd

Dunedin, Otago, 9012, New Zealand

RECRUITING

Related Publications (8)

• 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

• Gregori G, Righi O, Risso P, Boiardi G, Demuru G, Ferzetti A, Galli A, Ghisoni M, Lenzini S, Marenghi C, Mura C, Sacchetti R, Suzzani L. Reduction of group A beta-hemolytic streptococcus pharyngo-tonsillar infections associated with use of the oral probiotic Streptococcus salivarius K12: a retrospective observational study. Ther Clin Risk Manag. 2016 Jan 19;12:87-92. doi: 10.2147/TCRM.S96134. eCollection 2016.

  PMID: 26855579 BACKGROUND

• Di Pierro F, Adami T, Rapacioli G, Giardini N, Streitberger C. Clinical evaluation of the oral probiotic Streptococcus salivarius K12 in the prevention of recurrent pharyngitis and/or tonsillitis caused by Streptococcus pyogenes in adults. Expert Opin Biol Ther. 2013 Mar;13(3):339-43. doi: 10.1517/14712598.2013.758711. Epub 2013 Jan 4.

  PMID: 23286823 BACKGROUND

• Di Pierro F, Colombo M, Zanvit A, Rottoli AS. Positive clinical outcomes derived from using Streptococcus salivarius K12 to prevent streptococcal pharyngotonsillitis in children: a pilot investigation. Drug Healthc Patient Saf. 2016 Nov 21;8:77-81. doi: 10.2147/DHPS.S117214. eCollection 2016.

  PMID: 27920580 BACKGROUND

• Di Pierro F, Colombo M, Giuliani MG, Danza ML, Basile I, Bollani T, Conti AM, Zanvit A, Rottoli AS. Effect of administration of Streptococcus salivarius K12 on the occurrence of streptococcal pharyngo-tonsillitis, scarlet fever and acute otitis media in 3 years old children. Eur Rev Med Pharmacol Sci. 2016 Nov;20(21):4601-4606.

  PMID: 27874935 BACKGROUND

• Di Pierro F, Zanvit A, Nobili P, Risso P, Fornaini C. Cariogram outcome after 90 days of oral treatment with Streptococcus salivarius M18 in children at high risk for dental caries: results of a randomized, controlled study. Clin Cosmet Investig Dent. 2015 Oct 3;7:107-13. doi: 10.2147/CCIDE.S93066. eCollection 2015.

  PMID: 26491371 BACKGROUND

• Bardellini E, Amadori F, Gobbi E, Ferri A, Conti G, Majorana A. Does Streptococcus Salivarius Strain M18 Assumption Make Black Stains Disappear in Children? Oral Health Prev Dent. 2020 Apr 3;18(2):161-164. doi: 10.3290/j.ohpd.a43359.

  PMID: 32099975 BACKGROUND

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• John D Hale, PhD

  Blis Technologies Ltd

  STUDY DIRECTOR

• Rohit Jain, PhD

  Blis Technologies Ltd, Dunedin, New Zealand

  PRINCIPAL INVESTIGATOR

• John R Tagg, PhD

  Blis Technologies Ltd, Dunedin, New Zealand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John D Hale, PhD

CONTACT

+6434740988; john.hale@blis.co.nz

Rohit Jain, PhD

CONTACT

+6434740988; rohit.jain@blis.co.nz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: A staff member not part of the study group will be assigned to distribute blinded samples. The participant or the investigators will not be aware of the dose groups.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to one of the 12 groups consuming powder or lozenges containing Streptococcus salivarius K12 or S. salivarius M18 with or without prebiotic: Probiotic S. salivarius K12 lozenges Probiotic S. salivarius K12 lozenges containing prebiotic A Probiotic S. salivarius K12 lozenges containing prebiotic B Probiotic S. salivarius K12 lozenges containing prebiotic A and B Probiotic S. salivarius K12 powder Probiotic S. salivarius K12 powder containing prebiotic A Probiotic S. salivarius K12 powder containing prebiotic B Probiotic S. salivarius K12 powder containing prebiotic A and B Probiotic S. salivarius M18 lozenges Probiotic S. salivarius M18 lozenges containing prebiotic A Probiotic S. salivarius M18 lozenges der containing prebiotic B Probiotic S. salivarius M18 + lozenges containing prebiotic A and B

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 16, 2022
• Study Start: June 15, 2022
• Primary Completion: August 31, 2022
• Study Completion: September 15, 2022
• Last Updated: May 16, 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)