Clinical trial NCT05367518: Colonisation Efficacy of Oral Probiotic Fast Melt Powder
Official title: Assessment of Colonisation of Probiotic Bacterium Streptococcus Salivarius From a Fast Melt Powder Format to the Oral Cavity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Microbial Colonization
Keywords: Streptococcus salivarius K12
Oral Probiotic
Fast Melt Powder
Lead sponsor: BLIS Technologies Limited
Sponsor class: INDUSTRY
First posted: 2022-05-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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)
Primary purpose: BASIC_SCIENCE

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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in microbial colonization from baseline (Day 0) to 1 hour
timeFrame: 1 hours post intervention
measure: Change in microbial colonization from baseline (Day 0) to 8 hours
timeFrame: 8 hours post intervention
measure: Change in microbial colonization from baseline (Day 0) to 24 hours
timeFrame: 24 hours post intervention
measure: Change in microbial colonization from baseline (Day 0) to 48 hours post last dose
timeFrame: 48 hours after last dosing following 7 days of daily administration of probiotic
Secondary outcomes:
Other outcomes:
Locations:
city: Dunedin
country: New Zealand
facility: Blis Technologies Ltd
state: Otago
Study officials:
affiliation: Blis Technologies Ltd, Dunedin, New Zealand
name: John D Hale, PhD
role: STUDY_DIRECTOR
affiliation: Blis Technologies Ltd, Dunedin, New Zealand
name: John R Tagg, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Blis Technologies Ltd, Dunedin, New Zealand
name: Rohit Jain, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1128/AEM.02265-06. Epub 2006 Dec 28.
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.
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.
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.
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. doi: 10.2147/DHPS.S117214. eCollection 2016.
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.