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Colonisation Efficacy of Oral Probiotic Fast Melt Powder

Primary Purpose

Microbial Colonization

Status

Recruiting

Phase

Not Applicable

Locations

New Zealand

Study Type

Interventional

Intervention

Probiotic Streptococcus salivarius K12 Fast Melt Powder 1 Billion colony forming units /g)

Probiotic Streptococcus salivarius K12 Fast Melt Powder 100 Million colony forming units /g)

About this trial

This is an interventional basic science trial for Microbial Colonization focused on measuring Streptococcus salivarius K12, Oral Probiotic, Fast Melt Powder

Eligibility Criteria

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

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).

Sites / Locations

Blis Technologies LtdRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Streptococcus salivarius K12 Fast Melt Powder 1 Billion colony forming units /g

Streptococcus salivarius K12 Fast Melt Powder 100 million colony forming units /g

Arm Description

Probiotic Streptococcus salivarius K12 Fast Melt Powder (Dose 1: 1 Billion colony forming units /g)

Group B: Dose 2 Streptococcus salivarius K12 Fast Melt Powder (Dose 2: 100 Million colony forming unit/gram)

Outcomes

Primary Outcome Measures

Change in microbial colonization from baseline (Day 0) to 1 hour

Study will determine the change in microbial colonization efficacy of two different doses of Streptococcus salivarius K12 in a fast melt powder format. The saliva 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).

Change in microbial colonization from baseline (Day 0) to 8 hours

Study will determine the change in microbial colonization efficacy of two different doses of Streptococcus salivarius K12 in a fast melt powder format. The saliva 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).

Change in microbial colonization from baseline (Day 0) to 24 hours

Study will determine the change in microbial colonization efficacy of two different doses of Streptococcus salivarius K12 in a fast melt powder format. The saliva 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).

Change in microbial colonization from baseline (Day 0) to 48 hours post last dose

Study will determine the change in microbial colonization efficacy of two different doses of Streptococcus salivarius K12 in a fast melt powder format. The saliva Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to 48 hours after last dosing across two different formulations over 7 days, 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).

Secondary Outcome Measures

Full Information

NCT ID

NCT05367518

First Posted

May 3, 2022

Last Updated

May 5, 2022

Sponsor

BLIS Technologies Limited

1. Study Identification

Unique Protocol Identification Number

NCT05367518

Brief Title

Colonisation Efficacy of Oral Probiotic Fast Melt Powder

Official Title

Assessment of Colonisation of Probiotic Bacterium Streptococcus Salivarius From a Fast Melt Powder Format to the Oral Cavity

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

May 15, 2022 (Anticipated)

Primary Completion Date

May 25, 2022 (Anticipated)

Study Completion Date

June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

BLIS Technologies Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

To evaluate the colonisation efficacy (i.e. ability of the probiotic bacteria to remain in your mouth) of a fast melt powder that quickly dissolves in the mouth. The fast melt powder will contain a Streptococcus salivarius probiotic and the study is to be done in healthy adults.

Detailed Description

This is a double-blind, randomized controlled study with no cross over to evaluate the colonization efficacy of fast melt powders containing a commercially available probiotic bacterium Streptococcus salivarius K12. Participants will be randomly assigned to one of the 2 groups consuming Fast Melt powder containing two different doses of Streptococcus salivarius K12 over a seven day period. Saliva samples will be collected at predetermined time points pre and post intervention. Colonization 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

Microbial Colonization

Keywords

Streptococcus salivarius K12, Oral Probiotic, Fast Melt Powder

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 2 groups consuming Fast Melt powder containing two different doses of Streptococcus salivarius K12 : Group A: Probiotic Streptococcus salivarius K12 Fast Melt Powder (Dose 1: 1 Billion colony forming unit/gram) Group B: Streptococcus salivarius K12 Fast Melt Powder (Dose 2: 100 Million colony forming unit/gram)

Masking

ParticipantInvestigator

Masking Description

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.

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Streptococcus salivarius K12 Fast Melt Powder 1 Billion colony forming units /g

Arm Type

Active Comparator

Arm Description

Probiotic Streptococcus salivarius K12 Fast Melt Powder (Dose 1: 1 Billion colony forming units /g)

Arm Title

Streptococcus salivarius K12 Fast Melt Powder 100 million colony forming units /g

Arm Type

Active Comparator

Arm Description

Group B: Dose 2 Streptococcus salivarius K12 Fast Melt Powder (Dose 2: 100 Million colony forming unit/gram)

Intervention Type

Dietary Supplement

Intervention Name(s)

Probiotic Streptococcus salivarius K12 Fast Melt Powder 1 Billion colony forming units /g)

Intervention Description

Probiotic Streptococcus salivarius K12 products are commercially available in traditional formats such as chewable tablet (lozenge) for local delivery in the oral cavity to provide oral health benefits. In this study, a Fast Melt 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)

Probiotic Streptococcus salivarius K12 Fast Melt Powder 100 Million colony forming units /g)

Intervention Description

Probiotic Streptococcus salivarius K12 products are commercially available in traditional formats such as chewable table (lozenges) for local delivery in the oral cavity to provide oral health benefits. In this study, a Fast Melt Powder formulation will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity.

Primary Outcome Measure Information:

Title

Change in microbial colonization from baseline (Day 0) to 1 hour

Description

Time Frame

1 hours post intervention

Title

Change in microbial colonization from baseline (Day 0) to 8 hours

Description

Study will determine the change in microbial colonization efficacy of two different doses of Streptococcus salivarius K12 in a fast melt powder format. The saliva 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).

Time Frame

8 hours post intervention

Title

Change in microbial colonization from baseline (Day 0) to 24 hours

Description

Study will determine the change in microbial colonization efficacy of two different doses of Streptococcus salivarius K12 in a fast melt powder format. The saliva 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).

Time Frame

24 hours post intervention

Title

Change in microbial colonization from baseline (Day 0) to 48 hours post last dose

Description

Study will determine the change in microbial colonization efficacy of two different doses of Streptococcus salivarius K12 in a fast melt powder format. The saliva Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to 48 hours after last dosing across two different formulations over 7 days, 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

48 hours after last dosing following 7 days of daily administration of probiotic

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

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

john.hale@blis.co.nz

First Name & Middle Initial & Last Name or Official Title & Degree

John R Tagg, PhD

Phone

6434740988

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

Rohit Jain, 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

john.hale@blis.co.nz

First Name & Middle Initial & Last Name & Degree

Rohit Jain, PhD

Phone

+6434740988

rohit.jain@blis.co.nz

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Data and information included in the Protocol and Clinical Study Report will be shared to other researchers and/or in publications in due course.

IPD Sharing Time Frame

Study protocol, consent form before trail start. 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

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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

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PubMed Identifier

26855579

Citation

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.

Results Reference

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PubMed Identifier

23286823

Citation

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.

Results Reference

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PubMed Identifier

27920580

Citation

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.

Results Reference

background

PubMed Identifier

27874935

Citation

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.

Results Reference

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Colonisation Efficacy of Oral Probiotic Fast Melt Powder

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