Probiotic Toothpaste for Microbial Colonization

Microbial Colonization Clinical Trial

Official title:

Colonisation Efficacy of Streptococcus Salivarius M18 Toothpaste

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05480020
• Other study ID #: BLTCT2022/5
• Status: Recruiting
• Phase: N/A
• Start date: August 2022
• Est. completion date: October 2022

Study information

• Verified date: July 2022
• Source: BLIS Technologies Limited
• Contact: John D Hale, PhD
• Phone: +6434740988
• Email: john.hale[@]blis.co.nz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Microbial Colonization

Intervention

Other:
• Streptococcus salivarius M18 toothpaste
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.
• Streptococcus salivarius M18 toothpaste
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.
• Streptococcus salivarius M18 toothpaste
Probiotics Streptococcus salivarius M18 toothpaste 100 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.

Locations

Country	Name	City	State
New Zealand	Blis Technologies Ltd	Dunedin	Otago

Sponsors (1)

Lead Sponsor	Collaborator
John Hale

Country where clinical trial is conducted

New Zealand, 

References & Publications (4)

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;18(1):161-164. doi: 10.3290/j.ohpd.a43359. — View Citation

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. — View Citation

Burton JP, Wescombe PA, Macklaim JM, Chai MH, Macdonald K, Hale JD, Tagg J, Reid G, Gloor GB, Cadieux PA. Persistence of the oral probiotic Streptococcus salivarius M18 is dose dependent and megaplasmid transfer can augment their bacteriocin production and adhesion characteristics. PLoS One. 2013 Jun 13;8(6):e65991. doi: 10.1371/journal.pone.0065991. Print 2013. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Microbial colonization from baseline (Day 0) to 1 hour	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).	1 hour post intervention
Primary	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
Primary	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 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).	24 hours post intervention
Primary	Change in Microbial colonization from baseline (Day 0) to 24 hours post last dose	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).	24 hours after last dose following 7 days of daily brushing with probiotic toothpaste.