Probiotic Toothpaste to Assess Microbial Colonization

August 23, 2023 updated by: BLIS Technologies Limited

Colonisation Efficacy of Streptococcus Salivarius M18 Toothpaste

The aim of this study is to evaluate the colonization efficacy of probiotic toothpastes in healthy adults

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 2 groups for brushing teeth with a probiotic toothpaste containing two 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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • New Zealand
    • Otago
      • Dunedin, Otago, New Zealand, 9012
        • Blis Technologies Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active Comparator: Streptococcus salivarius M18 toothpaste dose 1
Streptococcus salivarius M18 toothpaste containing 1 million cfu/g
Other: Streptococcus salivarius M18 toothpaste (1 million cfu)

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.
Active Comparator: Active Comparator: Streptococcus salivarius M18 toothpaste dose 2
Streptococcus salivarius M18 toothpaste containing 10 million cfu/g
Other: Streptococcus salivarius M18 toothpaste (10 million cfu)

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Microbial colonization from baseline (Day 0) to 8 hours
Time Frame: 8 hours post intervention

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).
8 hours post intervention
Change in Microbial colonization from baseline (Day 0) to 1 hour
Time Frame: 1 hour post intervention

Study will determine the change in the microbial colonization efficacy of two 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).
1 hour post intervention
Change in Microbial colonization from baseline (Day 0) to 24 hours
Time Frame: 24 hours post intervention

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 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, GraphPad Prism).
24 hours post intervention
Change in Microbial colonization from baseline (Day 0) to 8 hours post last dose
Time Frame: 8 hours after last dose following 7 days of daily brushing with probiotic toothpaste.

Study will determine the change in the microbial colonization efficacy of two 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).
8 hours after last dose following 7 days of daily brushing with probiotic toothpaste.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BLIS Technologies Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2023

Primary Completion (Estimated)

November 29, 2023

Study Completion (Estimated)

February 28, 2024

Study Registration Dates

First Submitted

August 23, 2023

First Submitted That Met QC Criteria

August 23, 2023

First Posted (Actual)

August 29, 2023

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 23, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BLTCT2022/9

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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