Microbial Colonization of Dairy Free Oral Probiotics

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

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

Study Overview

• Status: Recruiting
• Conditions: Microbial Colonization
• Intervention / Treatment: Dietary supplement: Streptococcus salivarius M18 lozenges; Dietary supplement: Streptococcus salivarius M18 dairy free lozenges

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• New Zealand
  • Otago
    • Dunedin, Otago, New Zealand, 9012
      • Recruiting
      • Blis Technologies Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Streptococcus salivarius M18 lozenges; Streptococcus salivarius M18 lozenges containing dairy based Streptococcus salivarius M18	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.
Active Comparator: Streptococcus salivarius M18 dairy free lozenges; Streptococcus salivarius M18 lozenges containing dairy free Streptococcus salivarius M18	Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: John Hale
• Investigators: Study Director: John D D Hale, PhD, Blis Technologies Ltd; Study Director: John R Tagg, PhD, Blis Technologies Ltd, Dunedin, New Zealand

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: May 11, 2022
• First Submitted That Met QC Criteria: May 11, 2022
• First Posted (Actual): May 16, 2022

Study Record Updates

• Last Update Posted (Actual): May 16, 2022
• Last Update Submitted That Met QC Criteria: May 11, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: probiotic; chewable tablet; Streptococcus salivarius M18; microbial colonization; oral probiotic; dairy free; allergen free
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: BLTCT2022/4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data and information included in the Protocol and Clinical Study Report will be shared to other researchers and/or in publications in due course.
• IPD Sharing Time Frame: Study report 3 months after the completion of the study
• IPD Sharing Access Criteria: Summary study report will be shared by Principal Investigator upon request if not published in public literature
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No