Probiotic Toothpaste to Assess Microbial Colonization

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-02-28

Brief Summary

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

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Detailed Description

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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.

Conditions

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Microbial Colonization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly assigned to one of the 2 groups for brushing teeth with a probiotic toothpaste containing different doses of Streptococcus salivarius M18 Study Group A: BLIS M18 Toothpaste (10 million Cfu/dose) (n = 10) Study Group B: BLIS M18 Toothpaste (1 Million Cfu/dose) (n = 10)

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

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.

Study Groups

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Active Comparator: Streptococcus salivarius M18 toothpaste dose 1

Streptococcus salivarius M18 toothpaste containing 1 million cfu/g

Group Type ACTIVE_COMPARATOR

Streptococcus salivarius M18 toothpaste (1 million cfu)

Intervention Type OTHER

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: Streptococcus salivarius M18 toothpaste dose 2

Streptococcus salivarius M18 toothpaste containing 10 million cfu/g

Group Type ACTIVE_COMPARATOR

Streptococcus salivarius M18 toothpaste (10 million cfu)

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes