Colonisation Efficacy of Oral Probiotic Fast Melt Powder

NCT05367518 | Unknown

• 1 other identifier: BLTCT2022/1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Microbial Colonization

Keywords

Streptococcus salivarius K12; Oral Probiotic; Fast Melt Powder

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Streptococcus salivarius K12 Fast Melt Powder 1 Billion colony forming units /g

ACTIVE COMPARATOR

Probiotic Streptococcus salivarius K12 Fast Melt Powder (Dose 1: 1 Billion colony forming units /g)

Dietary Supplement: Probiotic Streptococcus salivarius K12 Fast Melt Powder 1 Billion colony forming units /g)

Streptococcus salivarius K12 Fast Melt Powder 100 million colony forming units /g

ACTIVE COMPARATOR

Group B: Dose 2 Streptococcus salivarius K12 Fast Melt Powder (Dose 2: 100 Million colony forming unit/gram)

Dietary Supplement: Probiotic Streptococcus salivarius K12 Fast Melt Powder 100 Million colony forming units /g)

Interventions

Probiotic Streptococcus salivarius K12 Fast Melt Powder 1 Billion colony forming units /g) DIETARY_SUPPLEMENT

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.

Streptococcus salivarius K12 Fast Melt Powder 1 Billion colony forming units /g

Probiotic Streptococcus salivarius K12 Fast Melt Powder 100 Million colony forming units /g) DIETARY_SUPPLEMENT

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.

Streptococcus salivarius K12 Fast Melt Powder 100 million colony forming units /g

Eligibility Criteria

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

You may qualify if:

• 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

• BLIS Technologies Limited: lead

Study Sites (1)

Blis Technologies Ltd

Dunedin, Otago, 9012, New Zealand

RECRUITING

Related Publications (6)

• 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. doi: 10.1128/AEM.02265-06. Epub 2006 Dec 28.

  PMID: 17194838 BACKGROUND

• 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.

  PMID: 26781236 BACKGROUND

• 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.

  PMID: 26855579 BACKGROUND

• 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.

  PMID: 23286823 BACKGROUND

• 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. doi: 10.2147/DHPS.S117214. eCollection 2016.

  PMID: 27920580 BACKGROUND

• 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.

  PMID: 27874935 BACKGROUND

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• John D Hale, PhD

  Blis Technologies Ltd, Dunedin, New Zealand

  STUDY DIRECTOR

• John R Tagg, PhD

  Blis Technologies Ltd, Dunedin, New Zealand

  PRINCIPAL INVESTIGATOR

• Rohit Jain, PhD

  Blis Technologies Ltd, Dunedin, New Zealand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John D Hale, PhD

CONTACT

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

John R Tagg, PhD

CONTACT

6434740988; john.tagg@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

Model Details: Participants will be randomly assigned to one of the 2 groups consuming Fast Melt powder containing two different doses of Streptococcus salivarius K12 : Group A: Probiotic Streptococcus salivarius K12 Fast Melt Powder (Dose 1: 1 Billion colony forming unit/gram) Group B: Streptococcus salivarius K12 Fast Melt Powder (Dose 2: 100 Million colony forming unit/gram)

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: May 10, 2022
• Study Start: May 15, 2022
• Primary Completion: May 25, 2022
• Study Completion: June 30, 2022
• Last Updated: May 10, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Study protocol, consent form before trail start. 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)