Probiotic Toothpaste to Assess Microbial Colonization

Not Applicable

Not yet recruiting

• Conditions: Microbial Colonization
• Interventions: Other: Streptococcus salivarius M18 toothpaste (10 million cfu); Other: Streptococcus salivarius M18 toothpaste (1 million cfu)

• Registration Number: NCT06015958
• Lead Sponsor: BLIS Technologies Limited

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 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 Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-08-23
• Study First Submitted QC: 2023-08-23
• Last Update Submitted: 2023-08-23
• Study First Posted: 2023-08-29
• Last Update Posted: 2023-08-29
• Study Start: 2023-10-01
• Primary Completion: 2023-11-29
• Study Completion: 2024-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Comparator: Streptococcus salivarius M18 toothpaste dose 2	Streptococcus salivarius M18 toothpaste (10 million cfu)	Streptococcus salivarius M18 toothpaste containing 10 million cfu/g
Active Comparator: Streptococcus salivarius M18 toothpaste dose 1	Streptococcus salivarius M18 toothpaste (1 million cfu)	Streptococcus salivarius M18 toothpaste containing 1 million cfu/g

Primary Outcome Measures

Name	Time	Method
Change in Microbial colonization from baseline (Day 0) to 8 hours	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).
Change in Microbial colonization from baseline (Day 0) to 1 hour	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).
Change in Microbial colonization from baseline (Day 0) to 24 hours	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).
Change in Microbial colonization from baseline (Day 0) to 8 hours post last dose	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).

Trial Locations

Locations (1)

Blis Technologies Ltd; 🇳🇿 Dunedin, Otago, New Zealand