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Probiotic Toothpaste for Microbial Colonization

Primary Purpose

Microbial Colonization

Status
Recruiting
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
Streptococcus salivarius M18 toothpaste
Streptococcus salivarius M18 toothpaste
Streptococcus salivarius M18 toothpaste
Sponsored by
John Hale
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Microbial Colonization focused on measuring Probiotic toothpaste, Streptococcus salivarius M18, microbial colonization, oral probiotic, toothpaste

Eligibility Criteria

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

Inclusion Criteria:

  • In general good health
  • Practise 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 Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Streptococcus salivarius M18 toothpaste dose 1

Streptococcus salivarius M18 toothpaste dose 2

Streptococcus salivarius M18 toothpaste dose 3

Arm Description

Streptococcus salivarius M18 toothpaste containing 1 million cfu/g

Streptococcus salivarius M18 toothpaste containing 10 million cfu/g

Streptococcus salivarius M18 toothpaste containing 100 million cfu/g

Outcomes

Primary Outcome Measures

Change in Microbial colonization from baseline (Day 0) to 1 hour
Study will determine the change in the microbial colonization efficacy of three different doses of S. salivarius M18 in a toothpaste format. Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 in a toothpaste format. The saliva Statistical analysis (e.g. ANOVA) will be carried out to compare the participants data from baseline to one hour after later across three 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, GraphPad Prism).
Change in Microbial colonization from baseline (Day 0) to 8 hours
Study will determine the change in the microbial colonization efficacy of three different doses of S. salivarius M18 in a toothpaste format. Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 in a toothpaste format. The saliva Statistical analysis (e.g. ANOVA) will be carried out to compare the participants data from baseline to one hour after later across three 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, GraphPad Prism).
Change in Microbial colonization from baseline (Day 0) to 24 hours
Study will determine the change in the microbial colonization efficacy of three different doses of S. salivarius M18 in a toothpaste format. Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 in a toothpaste format. The saliva Statistical analysis (e.g. ANOVA) will be carried out to compare the participants data from baseline to one hour after later across three 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, GraphPad Prism).
Change in Microbial colonization from baseline (Day 0) to 24 hours post last dose
Study will determine the change in the microbial colonization efficacy of three different doses of S. salivarius M18 in a toothpaste format. Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 in a toothpaste format. The saliva Statistical analysis (e.g. ANOVA) will be carried out to compare the participants data from baseline to one hour after later across three 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, GraphPad Prism).

Secondary Outcome Measures

Full Information

First Posted
July 27, 2022
Last Updated
July 28, 2022
Sponsor
John Hale
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1. Study Identification

Unique Protocol Identification Number
NCT05480020
Brief Title
Probiotic Toothpaste for Microbial Colonization
Official Title
Colonisation Efficacy of Streptococcus Salivarius M18 Toothpaste
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 2022 (Anticipated)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
October 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 evaluate the colonization efficacy of probiotic toothpastes in healthy adults
Detailed Description
This is a double blind randomized controlled study with no cross over to evaluate the colonization efficacy of toothpaste containing a commercially available probiotic bacterium Streptococcus salivarius M18. Participants will be randomly assigned to one of the 3 groups for brushing teeth with a probiotic toothpaste containing different doses of Streptococcus salivarius M18 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
Probiotic toothpaste, Streptococcus salivarius M18, microbial colonization, oral probiotic, toothpaste

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 3 groups for brushing teeth with a probiotic toothpaste containing different doses of Streptococcus salivarius M18 Study Group A: BLIS M18 Toothpaste (1 Million Cfu/dose) (n = 10) Study Group B: BLIS M18 Toothpaste (10 Million Cfu/dose) (n = 10) Study Group C: BLIS M18 Toothpaste (100 Million Cfu/dose) (n = 10)
Masking
Participant
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
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Streptococcus salivarius M18 toothpaste dose 1
Arm Type
Active Comparator
Arm Description
Streptococcus salivarius M18 toothpaste containing 1 million cfu/g
Arm Title
Streptococcus salivarius M18 toothpaste dose 2
Arm Type
Active Comparator
Arm Description
Streptococcus salivarius M18 toothpaste containing 10 million cfu/g
Arm Title
Streptococcus salivarius M18 toothpaste dose 3
Arm Type
Active Comparator
Arm Description
Streptococcus salivarius M18 toothpaste containing 100 million cfu/g
Intervention Type
Other
Intervention Name(s)
Streptococcus salivarius M18 toothpaste
Intervention Description
Probiotics Streptococcus salivarius M18 toothpaste 1 million cfu/g In this study, a toothpaste formulation containing S. salivarius M18 will be evaluated for its potential for delivering the probiotic to the oral cavity.
Intervention Type
Other
Intervention Name(s)
Streptococcus salivarius M18 toothpaste
Intervention Description
Probiotics Streptococcus salivarius M18 toothpaste 10 million cfu/g In this study, a toothpaste formulation containing S. salivarius M18 will be evaluated for its potential for delivering the probiotic to the oral cavity.
Intervention Type
Other
Intervention Name(s)
Streptococcus salivarius M18 toothpaste
Intervention Description
Probiotics Streptococcus salivarius M18 toothpaste 100 million cfu/g In this study, a toothpaste formulation containing S. salivarius M18 will be evaluated for its potential for delivering the probiotic to the oral cavity.
Primary Outcome Measure Information:
Title
Change in Microbial colonization from baseline (Day 0) to 1 hour
Description
Study will determine the change in the microbial colonization efficacy of three different doses of S. salivarius M18 in a toothpaste format. Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 in a toothpaste format. The saliva Statistical analysis (e.g. ANOVA) will be carried out to compare the participants data from baseline to one hour after later across three 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, GraphPad Prism).
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 the microbial colonization efficacy of three different doses of S. salivarius M18 in a toothpaste format. Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 in a toothpaste format. The saliva Statistical analysis (e.g. ANOVA) will be carried out to compare the participants data from baseline to one hour after later across three 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, GraphPad Prism).
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 the microbial colonization efficacy of three different doses of S. salivarius M18 in a toothpaste format. Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 in a toothpaste format. The saliva Statistical analysis (e.g. ANOVA) will be carried out to compare the participants data from baseline to one hour after later across three 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, GraphPad Prism).
Time Frame
24 hours post intervention
Title
Change in Microbial colonization from baseline (Day 0) to 24 hours post last dose
Description
Study will determine the change in the microbial colonization efficacy of three different doses of S. salivarius M18 in a toothpaste format. Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 in a toothpaste format. The saliva Statistical analysis (e.g. ANOVA) will be carried out to compare the participants data from baseline to one hour after later across three 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, GraphPad Prism).
Time Frame
24 hours after last dose following 7 days of daily brushing with probiotic toothpaste.

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 Practise 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
Rohit Jain, PhD
Phone
+6434740988
Email
rohit.jain@blis.co.nz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John R Tagg, PhD
Organizational Affiliation
Blis Technologies
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rohit Jain, PhD
Organizational Affiliation
Blis Technologies
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John D Hale, PhD
Organizational Affiliation
Blis Technologies
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

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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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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
background
PubMed Identifier
23785463
Citation
Burton JP, Wescombe PA, Macklaim JM, Chai MH, Macdonald K, Hale JD, Tagg J, Reid G, Gloor GB, Cadieux PA. Persistence of the oral probiotic Streptococcus salivarius M18 is dose dependent and megaplasmid transfer can augment their bacteriocin production and adhesion characteristics. PLoS One. 2013 Jun 13;8(6):e65991. doi: 10.1371/journal.pone.0065991. Print 2013.
Results Reference
background
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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Probiotic Toothpaste for Microbial Colonization

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