Microbial Colonization of Oral Probiotics

Microbial Colonization Clinical Trial

Official title:

Assessment of Colonisation of Probiotic Bacterium Streptococcus Salivarius in the Oral Cavity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05375383
• Other study ID #: BLTCT2022/3
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2022
• Est. completion date: September 15, 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 and powders containing specific prebiotics in healthy adults

Description:

This is a double-blind, randomized controlled colonization pilot study with no cross over to evaluate the colonization efficacy of lozenges and powders containing two different commercially available probiotic bacteria (S. salivarius K12 ) or S. salivarius M18 with or without 2 different prebiotic sugars or their combinations.

Participants will be randomly assigned to one of the 12 groups consuming probiotic lozenge or powder containing Streptococcus salivarius K12 or S. salivarius M18 with or without prebiotics (e.g. sugars that may promote probiotic activity) over a seven day period. Saliva samples will be collected at predetermined time points pre and post intervention. Colonisation efficacy will be determined by enumerating the probiotic in the saliva samples using standard microbiological techniques.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 15, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion criteria:

1. Male or Female 18y - 80y age

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

3. 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 K12 lozenge
In this study, a lozenge will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity.
• Probiotic S. salivarius K12 lozenges containing prebiotic A
In this study, a lozenge containing a prebiotic will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity.
• Probiotic S. salivarius K12 lozenges containing prebiotic B
In this study, a lozenge containing a prebiotic will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity.
• Probiotic S. salivarius K12 lozenges containing prebiotics A and B
In this study, a lozenge containing two prebiotics will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity.
• Probiotic S. salivarius K12 powder
In this study, a powder will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity
• Probiotic S. salivarius K12 powder containing prebiotic A
In this study, a powder containing a prebiotic will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity
• Probiotic S. salivarius K12 powder containing prebiotic B
In this study, a powder containing a prebiotic will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity
• Probiotic S. salivarius K12 powder containing prebiotics A and B
In this study, a powder containing two prebiotics will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity
• Probiotic S. salivarius M18 lozenges
In this study, a lozenge containing will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 to the oral cavity.
• Probiotic S. salivarius M18 lozenges containing prebiotic A
In this study, a lozenge containing a prebiotic will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 to the oral cavity.
• Probiotic S. salivarius M18 lozenges containing prebiotic B
In this study, a lozenge containing a prebiotic will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 to the oral cavity.
• Probiotic S. salivarius M18 + lozenges containing prebiotic A and B
In this study, a lozenge containing two prebiotics 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
BLIS Technologies Limited

Country where clinical trial is conducted

New Zealand, 

References & Publications (8)

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, Chilcott CN, Wescombe PA, Tagg JR. Extended Safety Data for the Oral Cavity Probiotic Streptococcus salivarius K12. Probiotics Antimicrob Proteins. 2010 Oct;2(3):135-44. doi: 10.1007/s12602-010-9045-4. — View Citation

Di Pierro F, Adami T, Rapacioli G, Giardini N, Streitberger C. Clinical evaluation of the oral probiotic Streptococcus salivarius K12 in the prevention of recurrent pharyngitis and/or tonsillitis caused by Streptococcus pyogenes in adults. Expert Opin Biol Ther. 2013 Mar;13(3):339-43. doi: 10.1517/14712598.2013.758711. Epub 2013 Jan 4. — View Citation

Di Pierro F, Colombo M, Giuliani MG, Danza ML, Basile I, Bollani T, Conti AM, Zanvit A, Rottoli AS. Effect of administration of Streptococcus salivarius K12 on the occurrence of streptococcal pharyngo-tonsillitis, scarlet fever and acute otitis media in 3 years old children. Eur Rev Med Pharmacol Sci. 2016 Nov;20(21):4601-4606. — View Citation

Di Pierro F, Colombo M, Zanvit A, Rottoli AS. Positive clinical outcomes derived from using Streptococcus salivarius K12 to prevent streptococcal pharyngotonsillitis in children: a pilot investigation. Drug Healthc Patient Saf. 2016 Nov 21;8:77-81. eCollection 2016. — 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

Gregori G, Righi O, Risso P, Boiardi G, Demuru G, Ferzetti A, Galli A, Ghisoni M, Lenzini S, Marenghi C, Mura C, Sacchetti R, Suzzani L. Reduction of group A beta-hemolytic streptococcus pharyngo-tonsillar infections associated with use of the oral probiotic Streptococcus salivarius K12: a retrospective observational study. Ther Clin Risk Manag. 2016 Jan 19;12:87-92. doi: 10.2147/TCRM.S96134. eCollection 2016. — View Citation

Hyink O, Wescombe PA, Upton M, Ragland N, Burton JP, Tagg JR. Salivaricin A2 and the novel lantibiotic salivaricin B are encoded at adjacent loci on a 190-kilobase transmissible megaplasmid in the oral probiotic strain Streptococcus salivarius K12. Appl Environ Microbiol. 2007 Feb;73(4):1107-13. Epub 2006 Dec 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in microbial colonization from baseline (Day 0) to 1 hour for S. salivarius K12 lozenges	Study will determine the change in microbial colonization efficacy of Streptococcus salivarius K12 with or without prebiotics from a lozenge format. The statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to one hour after later across 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
Primary	Change in microbial colonization from baseline (Day 0) to 8 hours or S. salivarius K12 lozenges	Study will determine the change in microbial colonization efficacy of Streptococcus salivarius K12 with or without prebiotics from a lozenge format. The statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to eight hours after later across 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
Primary	Change in microbial colonization from baseline (Day 0) to 24 hours or S. salivarius K12 lozenges	Study will determine the change in microbial colonization efficacy of Streptococcus salivarius K12 with or without prebiotics from a lozenge format. The statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to 24 hours after later across 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
Primary	Change in microbial colonization from baseline (Day 0) to 48 hours or S. salivarius K12 lozenges	Study will determine the change in microbial colonization efficacy of Streptococcus salivarius K12 with or without prebiotics from a lozenge format. The statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to 48hours after later across 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
Primary	in microbial colonization from baseline (Day 0) to 1 hour for S. salivarius K12 powder format	Study will determine the change in microbial colonization efficacy of Streptococcus salivarius K12 with or without prebiotics from a powder format. The 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
Primary	in microbial colonization from baseline (Day 0) to 8 hour for S. salivarius K12 powder format	Study will determine the change in microbial colonization efficacy of Streptococcus salivarius K12 with or without prebiotics from a powder format. The statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to 8 hours 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 hours
Primary	in microbial colonization from baseline (Day 0) to 24 hours for S. salivarius K12 powder format	Study will determine the change in microbial colonization efficacy of Streptococcus salivarius K12 with or without prebiotics from a powder format. The statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to 24 hours 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
Primary	in microbial colonization from baseline (Day 0) to 48 hours for S. salivarius K12 powder format	Study will determine the change in microbial colonization efficacy of Streptococcus salivarius K12 with or without prebiotics from a powder format. The statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to 48 hours 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
Primary	Change in microbial colonization from baseline (Day 0) to 1 hour for S. salivarius M18 lozenges	Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 with or without prebiotics from a lozenge format. The statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to one hour after later across 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
Primary	Change in microbial colonization from baseline (Day 0) to 8 hours for S. salivarius M18 lozenges	Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 with or without prebiotics from a lozenge format. The statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to 8 hour after later across 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
Primary	Change in microbial colonization from baseline (Day 0) to 24 hours for S. salivarius M18 lozenges	Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 with or without prebiotics from a lozenge format. The statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to 24 hour after later across 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
Primary	Change in microbial colonization from baseline (Day 0) to 48 hours for S. salivarius M18 lozenges	Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 with or without prebiotics from a lozenge format. The statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to 48 hour after later across 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