Probiotic Toothpaste for Microbial Colonization

John Hale

Status: Enrolling

Conditions: Microbial Colonization

Treatments: Other: Streptococcus salivarius M18 toothpaste

Study type: Interventional

Funder types: Industry

Identifiers

NCT05480020

BLTCT2022/5

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts 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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 3 patient groups

Streptococcus salivarius M18 toothpaste dose 1

Active Comparator group

Description:

Streptococcus salivarius M18 toothpaste containing 1 million cfu/g

Treatment:

Other: Streptococcus salivarius M18 toothpaste

Other: Streptococcus salivarius M18 toothpaste

Other: Streptococcus salivarius M18 toothpaste

Streptococcus salivarius M18 toothpaste dose 2

Active Comparator group

Description:

Streptococcus salivarius M18 toothpaste containing 10 million cfu/g

Treatment:

Other: Streptococcus salivarius M18 toothpaste

Other: Streptococcus salivarius M18 toothpaste

Other: Streptococcus salivarius M18 toothpaste

Streptococcus salivarius M18 toothpaste dose 3

Active Comparator group

Description:

Streptococcus salivarius M18 toothpaste containing 100 million cfu/g

Treatment:

Other: Streptococcus salivarius M18 toothpaste

Other: Streptococcus salivarius M18 toothpaste

Other: Streptococcus salivarius M18 toothpaste