Microbial Colonization of Dairy Free Oral Probiotics

NCT05375396 | Unknown

• 1 other identifier: BLTCT2022/4
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Microbial Colonization

Keywords

Streptococcus salivarius M18; dairy free; allergen free; probiotic; microbial colonization; oral probiotic; chewable tablet

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

Streptococcus salivarius M18 lozenges

ACTIVE COMPARATOR

Streptococcus salivarius M18 lozenges containing dairy based Streptococcus salivarius M18

Dietary Supplement: Streptococcus salivarius M18 lozenges

Streptococcus salivarius M18 dairy free lozenges

ACTIVE COMPARATOR

Streptococcus salivarius M18 lozenges containing dairy free Streptococcus salivarius M18

Dietary Supplement: Streptococcus salivarius M18 dairy free lozenges

Interventions

Streptococcus salivarius M18 lozenges DIETARY_SUPPLEMENT

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 lozenges

Streptococcus salivarius M18 dairy free lozenges DIETARY_SUPPLEMENT

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.

Streptococcus salivarius M18 dairy free lozenges

Eligibility Criteria

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

You may qualify if:

• Male or Female 18y - 80y age
• In general good health 18 - 80 years of age.
• Practice 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

• John Hale: lead

Study Sites (1)

Blis Technologies Ltd

Dunedin, Otago, 9012, New Zealand

RECRUITING

Related Publications (4)

• 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

• 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

• 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.

  PMID: 23785463 BACKGROUND

• 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

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• John D D Hale, PhD

  Blis Technologies Ltd

  STUDY DIRECTOR

• Rohit Jain, PhD

  Blis Technologies Ltd, Dunedin, New Zealand

  PRINCIPAL INVESTIGATOR

• John R Tagg, PhD

  Blis Technologies Ltd, Dunedin, New Zealand

  STUDY DIRECTOR

Central Study Contacts

John D Hale, PhD

CONTACT

+6434740988; john.hale@blis.co.nz

Rohit Jain, PhD

CONTACT

+6434740988; rohit.jain@blis.co.nz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• 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 INVESTIGATOR
• PI Title: Chief Technology Officer

Model Details: Probiotic Streptococcus salivarius M18 lozenges Probiotics dairy free Streptococcus salivarius M18 lozenges

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 16, 2022
• Study Start: June 1, 2022
• Primary Completion: July 1, 2022
• Study Completion: August 1, 2022
• Last Updated: May 16, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Study report 3 months after the completion of the study
• Access Criteria: Summary study report will be shared by Principal Investigator upon request if not published in public literature

Locations

NZ (1)