Probiotic Toothpaste to Assess Microbial Colonization

NCT06015958 | Unknown

• 1 other identifier: BLTCT2022/9
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Microbial Colonization

Keywords

probiotic toothpaste; Streptococcus salivarius M18; Microbial colonization; Oral Probiotic; Toothpaste

Outcome Measures

Primary Outcomes (4)

• Change in Microbial colonization from baseline (Day 0) to 1 hour

  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 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).

  8 hours post intervention

• 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 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

  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.

Study Arms (2)

Active Comparator: Streptococcus salivarius M18 toothpaste dose 1

ACTIVE COMPARATOR

Streptococcus salivarius M18 toothpaste containing 1 million cfu/g

Other: Streptococcus salivarius M18 toothpaste (1 million cfu)

Active Comparator: Streptococcus salivarius M18 toothpaste dose 2

ACTIVE COMPARATOR

Streptococcus salivarius M18 toothpaste containing 10 million cfu/g

Other: Streptococcus salivarius M18 toothpaste (10 million cfu)

Interventions

Streptococcus salivarius M18 toothpaste (1 million cfu) 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 1

Streptococcus salivarius M18 toothpaste (10 million cfu) 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.

Active Comparator: Streptococcus salivarius M18 toothpaste dose 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In general good health
• Practise good oral hygiene

You may not qualify if:

• 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).

Sponsors & Collaborators

• BLIS Technologies Limited: lead

Study Sites (1)

Blis Technologies Ltd

Dunedin, Otago, 9012, New Zealand

Location

Related Publications (3)

• 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.

  PMID: 23449874 BACKGROUND

• 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 Apr 3;18(2):161-164. doi: 10.3290/j.ohpd.a43359.

  PMID: 32099975 BACKGROUND

• 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.

  PMID: 26491371 BACKGROUND

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: August 29, 2023
• Study Start: October 1, 2023
• Primary Completion: November 29, 2023
• Study Completion: February 28, 2024
• Last Updated: August 29, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)