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Colonisation Efficacy of a Probiotic Chewing Gum.

Primary Purpose

Microbial Colonization

Status

Recruiting

Phase

Not Applicable

Locations

New Zealand

Study Type

Interventional

Intervention

Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum (chew 5 minutes)

Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum (chew 10 minutes)

About this trial

This is an interventional basic science trial for Microbial Colonization

Eligibility Criteria

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

Inclusion Criteria: In general, good health Practice good oral hygiene Exclusion Criteria: Have a history of autoimmune disease or are immune compromised. Are on concurrent antibiotic therapy, or regular antibiotic use within last one week People with allergies or sensitivities to dairy.

Sites / Locations

Blis Technologies LtdRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum: Chew 5 minutes

Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum: Chew 10 minutes

Arm Description

Streptococcus salivarius M18 chewing gum 1 billion cfu chewing the gum for 5 minutes duration.

Streptococcus salivarius M18 chewing gum 1 billion cfu chewing the gum for 10 minutes duration.

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 Streptococcus salivarius M18 chewing gum after two different times of chewing (5 vs 10 minutes). The statistical analysis will be carried out to compare the participants saliva data from baseline to post 1 hour across two different times of chewing exposure with a level of significance of p<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software.

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

Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 chewing gum after two different times of chewing (5 vs 10 minutes). The statistical analysis will be carried out to compare the participants saliva data from baseline to post 8 hours across two different times of chewing exposure with a level of significance of p<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software.

Change in Microbial colonization from baseline (Day 0) to 8 hours post last dose.

Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 chewing gum after two different times of chewing (5 vs 10 minutes). The statistical analysis will be carried out to compare the participants saliva data from baseline to post 8 hours following twice daily administration of probiotic, across two different times of chewing exposure with a level of significance of p<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software.

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

Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 chewing gum after two different times of chewing (5 vs 10 minutes). The statistical analysis will be carried out to compare the participants saliva data from baseline to post 48 hours following twice daily administration of probiotic, across two different times of chewing exposure with a level of significance of p<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software.

Secondary Outcome Measures

Full Information

NCT ID

NCT05624177

First Posted

November 14, 2022

Last Updated

November 21, 2022

Sponsor

BLIS Technologies Limited

1. Study Identification

Unique Protocol Identification Number

NCT05624177

Brief Title

Colonisation Efficacy of a Probiotic Chewing Gum.

Official Title

Colonisation Efficacy of a Probiotic Chewing Gum.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 2022 (Anticipated)

Primary Completion Date

January 2023 (Anticipated)

Study Completion Date

March 2023 (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 colonization efficacy (the ability of a probiotic bacteria to remain in the mouth) delivered in a chewing gum format. The chewing gum contains Streptococcus salivarius probiotic and the study is to be done in health adults.

Detailed Description

This is a single blind, randomized controlled study to evaluate the colonization effectiveness of a chewing gum containing a commercially available probiotic bacterium. Participants will be randomly assigned to one of the two groups consuming chewing gum containing Streptococcus salivarius M18 over a 7-day period. Saliva samples will be collected at pre determined points (pre and post intervention). Colonization efficacy will be determined by enumerating the probiotic from 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

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 two groups consuming chewing gum containing Streptococcus salivarius M18. Group A: Probiotic Streptococcus salivarius M18 chewing gum (dose: 1 billion colony forming units per gum tablet) and chew for 5 minutes duration. Group B: Probiotic Streptococcus salivarius M18 chewing gum (dose: 1 billion colony forming units per gum tablet) and chew for 10-20 minutes

Masking

Investigator

Masking Description

A Staff member, not part of the study group will be assigned to distribute blinded samples. The investigator will not be are of the dose groups.

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum: Chew 5 minutes

Arm Type

Active Comparator

Arm Description

Streptococcus salivarius M18 chewing gum 1 billion cfu chewing the gum for 5 minutes duration.

Arm Title

Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum: Chew 10 minutes

Arm Type

Active Comparator

Arm Description

Streptococcus salivarius M18 chewing gum 1 billion cfu chewing the gum for 10 minutes duration.

Intervention Type

Dietary Supplement

Intervention Name(s)

Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum (chew 5 minutes)

Intervention Description

Probiotic Streptococcus salivarius M18 products are commercially available in traditional formats such as a chewable tablet (lozenge) for local delivery to the oral cavity to provide health benefits. In this study, a chewing gum 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 probiotic 1 billion colony forming units chewing gum (chew 10 minutes)

Intervention Description

Primary Outcome Measure Information:

Title

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

Description

Time Frame

1 hour 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 Streptococcus salivarius M18 chewing gum after two different times of chewing (5 vs 10 minutes). The statistical analysis will be carried out to compare the participants saliva data from baseline to post 8 hours across two different times of chewing exposure with a level of significance of p<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software.

Time Frame

8 hours post intervention.

Title

Change in Microbial colonization from baseline (Day 0) to 8 hours post last dose.

Description

Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 chewing gum after two different times of chewing (5 vs 10 minutes). The statistical analysis will be carried out to compare the participants saliva data from baseline to post 8 hours following twice daily administration of probiotic, across two different times of chewing exposure with a level of significance of p<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software.

Time Frame

8 hours past last dose following 7 days of twice daily administration of probiotic.

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 Streptococcus salivarius M18 chewing gum after two different times of chewing (5 vs 10 minutes). The statistical analysis will be carried out to compare the participants saliva data from baseline to post 48 hours following twice daily administration of probiotic, across two different times of chewing exposure with a level of significance of p<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software.

Time Frame

48 hours past last dose following 7 days of twice 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

Central Contact Person:

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

John D Hale, PhD

Phone

+64211735540

john.hale@blis.co.nz

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

Rohit Jain, PhD

Phone

+64211347338

rohit.jain@blis.co.nz

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

12. IPD Sharing Statement

Plan to Share IPD

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

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PubMed Identifier

32099975

Citation

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;18(1):161-164. doi: 10.3290/j.ohpd.a43359.

Results Reference

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PubMed Identifier

23449874

Citation

Burton JP, Drummond BK, Chilcott CN, Tagg JR, Thomson WM, Hale JDF, Wescombe PA. Influence of the probiotic Streptococcus salivarius strain M18 on indices of dental health in children: a randomized double-blind, placebo-controlled trial. J Med Microbiol. 2013 Jun;62(Pt 6):875-884. doi: 10.1099/jmm.0.056663-0. Epub 2013 Feb 28.

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

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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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PubMed Identifier

26491371

Citation

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.

Results Reference

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Colonisation Efficacy of a Probiotic Chewing Gum.

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