Microbial Colonization of Dairy Free Oral Probiotics

Microbial Colonization Clinical Trial

Official title:

Assessment of Colonization of Dairy Free Probiotic Bacterium Streptococcus Salivarius From Lozenges to the Oral Cavity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05375396
• Other study ID #: BLTCT2022/4
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: August 1, 2022

Study information

• Verified date: May 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 lozenges containing dairy and dairy free probiotic Streptococcus salivarius M18, in healthy adults

Description:

This is a double-blind, randomized controlled colonization pilot study with no cross over to evaluate the colonization efficacy of two different lozenges containing either dairy or dairy free probiotic bacteria Streptococcus salivarius M18.

Participants will be randomly assigned to one of the 2 groups consuming probiotic lozenge containing dairy free Streptococcus salivarius M18 or dairy based 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: August 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion criteria:

Male or Female 18y - 80y age

1. In general good health 18 - 80 years of age.

2. Practice 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

Dietary Supplement:
• Streptococcus salivarius M18 lozenges
In this study, a lozenge formulation containing dairy based S. salivarius M18 will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 to the oral cavity.
• Streptococcus salivarius M18 dairy free lozenges
In this study, a lozenge formulation containing dairy free S. salivarius M18 will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 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 of S. salivarius M18 from Day 0 (baseline) to 1 hour	Study will determine the change in microbial colonization efficacy of dairy based Streptococcus salivarius M18 in a Lozenge format. The saliva Statistical analysis (e.g. Students t-test) 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).	1 hour post intervention
Primary	Change in microbial colonization of S. salivarius M18 from Day 0 (baseline) to 8 hours	Study will determine the change in microbial colonization efficacy of dairy based Streptococcus salivarius M18 in a Lozenge format. The saliva Statistical analysis (e.g. Students t-test) 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).	8 hour post intervention
Primary	Change in microbial colonization of S. salivarius M18 from Day 0 (baseline) to 24 hours	Study will determine the change in microbial colonization efficacy of dairy based Streptococcus salivarius M18 in a Lozenge format. The saliva Statistical analysis (e.g. Students t-test) 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).	24 hours post intervention
Primary	Change in microbial colonization of S. salivarius M18 from Day 0 (baseline) to 48hours	Study will determine the change in microbial colonization efficacy of dairy based Streptococcus salivarius M18 in a Lozenge format. The saliva Statistical analysis (e.g. Students t-test) 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).	48 hours post intervention
Primary	Change in microbial colonization of dairy free S. salivarius M18 from Day 0 (baseline) to 1 hour	Study will determine the change in microbial colonization efficacy of dairy based Streptococcus salivarius M18 in a Lozenge format. The saliva Statistical analysis (e.g. Students t-test) 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).	1 hour post intervention
Primary	Change in microbial colonization of dairy free S. salivarius M18 from Day 0 (baseline) to 8 hour	Study will determine the change in microbial colonization efficacy of dairy based Streptococcus salivarius M18 in a Lozenge format. The saliva Statistical analysis (e.g. Students t-test) 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).	8 hour post intervention
Primary	Change in microbial colonization of dairy free S. salivarius M18 from Day 0 (baseline) to 24 hour	Study will determine the change in microbial colonization efficacy of dairy based Streptococcus salivarius M18 in a Lozenge format. The saliva Statistical analysis (e.g. Students t-test) 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).	24 hour post intervention
Primary	Change in microbial colonization of dairy free S. salivarius M18 from Day 0 (baseline) to 48 hour	Study will determine the change in microbial colonization efficacy of dairy based Streptococcus salivarius M18 in a Lozenge format. The saliva Statistical analysis (e.g. Students t-test) 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).	48 hour post intervention