Colonisation Efficacy of Oral Probiotic Fast Melt Powder

Microbial Colonization Clinical Trial

Official title:

Assessment of Colonisation of Probiotic Bacterium Streptococcus Salivarius From a Fast Melt Powder Format to the Oral Cavity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05367518
• Other study ID #: BLTCT2022/1
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2022
• Est. completion date: June 30, 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

To evaluate the colonisation efficacy (i.e. ability of the probiotic bacteria to remain in your mouth) of a fast melt powder that quickly dissolves in the mouth. The fast melt powder will contain a Streptococcus salivarius probiotic and the study is to be done in healthy adults.

Description:

This is a double-blind, randomized controlled study with no cross over to evaluate the colonization efficacy of fast melt powders containing a commercially available probiotic bacterium Streptococcus salivarius K12.

Participants will be randomly assigned to one of the 2 groups consuming Fast Melt powder containing two different doses of Streptococcus salivarius K12 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: 20
• Est. completion date: June 30, 2022
• Est. primary completion date: May 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

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:
• Probiotic Streptococcus salivarius K12 Fast Melt Powder 1 Billion colony forming units /g)
Probiotic Streptococcus salivarius K12 products are commercially available in traditional formats such as chewable tablet (lozenge) for local delivery in the oral cavity to provide oral health benefits. In this study, a Fast Melt Powder formulation will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity.
• Probiotic Streptococcus salivarius K12 Fast Melt Powder 100 Million colony forming units /g)
Probiotic Streptococcus salivarius K12 products are commercially available in traditional formats such as chewable table (lozenges) for local delivery in the oral cavity to provide oral health benefits. In this study, a Fast Melt Powder formulation will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 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 (6)

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

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	Study will determine the change in microbial colonization efficacy of two different doses of Streptococcus salivarius K12 in a fast melt powder 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 hours post intervention
Primary	Change in microbial colonization from baseline (Day 0) to 8 hours	Study will determine the change in microbial colonization efficacy of two different doses of Streptococcus salivarius K12 in a fast melt powder format. The saliva 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 post intervention
Primary	Change in microbial colonization from baseline (Day 0) to 24 hours	Study will determine the change in microbial colonization efficacy of two different doses of Streptococcus salivarius K12 in a fast melt powder format. The saliva 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 post intervention
Primary	Change in microbial colonization from baseline (Day 0) to 48 hours post last dose	Study will determine the change in microbial colonization efficacy of two different doses of Streptococcus salivarius K12 in a fast melt powder format. The saliva Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to 48 hours after last dosing across two different formulations over 7 days, 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 after last dosing following 7 days of daily administration of probiotic