Clinical trial NCT05375383: Microbial Colonization of Oral Probiotics
Official title: Assessment of Colonisation of Probiotic Bacterium Streptococcus Salivarius in the Oral Cavity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Microbial Colonization
Keywords: Streptococcus salivarius K12
Probiotic
microbial colonization
oral probiotic
lozenges
powder
prebiotic
Streptococcus salivarius M18
Lead sponsor: BLIS Technologies Limited
Sponsor class: INDUSTRY
First posted: 2022-05-16
Enrollment: 60
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 12 groups consuming powder or lozenges containing Streptococcus salivarius K12 or S. salivarius M18 with or without prebiotic:

Probiotic S. salivarius K12 lozenges Probiotic S. salivarius K12 lozenges containing prebiotic A Probiotic S. salivarius K12 lozenges containing prebiotic B Probiotic S. salivarius K12 lozenges containing prebiotic A and B

Probiotic S. salivarius K12 powder Probiotic S. salivarius K12 powder containing prebiotic A Probiotic S. salivarius K12 powder containing prebiotic B Probiotic S. salivarius K12 powder containing prebiotic A and B

Probiotic S. salivarius M18 lozenges Probiotic S. salivarius M18 lozenges containing prebiotic A Probiotic S. salivarius M18 lozenges der containing prebiotic B Probiotic S. salivarius M18 + lozenges containing prebiotic A and B
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to evaluate the colonization efficacy of probiotic lozenges and powders containing specific prebiotics in healthy adults

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in microbial colonization from baseline (Day 0) to 1 hour for S. salivarius K12 lozenges
timeFrame: 1 hour
measure: Change in microbial colonization from baseline (Day 0) to 8 hours or S. salivarius K12 lozenges
timeFrame: 8 hour
measure: Change in microbial colonization from baseline (Day 0) to 24 hours or S. salivarius K12 lozenges
timeFrame: 24 hour
measure: Change in microbial colonization from baseline (Day 0) to 48 hours or S. salivarius K12 lozenges
timeFrame: 48 hour
measure: in microbial colonization from baseline (Day 0) to 1 hour for S. salivarius K12 powder format
timeFrame: 1 hour
measure: in microbial colonization from baseline (Day 0) to 8 hour for S. salivarius K12 powder format
timeFrame: 8 hours
measure: in microbial colonization from baseline (Day 0) to 24 hours for S. salivarius K12 powder format
timeFrame: 24 hours
measure: in microbial colonization from baseline (Day 0) to 48 hours for S. salivarius K12 powder format
timeFrame: 48 hours
measure: Change in microbial colonization from baseline (Day 0) to 1 hour for S. salivarius M18 lozenges
timeFrame: 1 hour
measure: Change in microbial colonization from baseline (Day 0) to 8 hours for S. salivarius M18 lozenges
timeFrame: 8 hour
measure: Change in microbial colonization from baseline (Day 0) to 24 hours for S. salivarius M18 lozenges
timeFrame: 24 hour
measure: Change in microbial colonization from baseline (Day 0) to 48 hours for S. salivarius M18 lozenges
timeFrame: 48 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Dunedin
country: New Zealand
facility: Blis Technologies Ltd
state: Otago
Study officials:
affiliation: Blis Technologies Ltd
name: John D Hale, PhD
role: STUDY_DIRECTOR
affiliation: Blis Technologies Ltd, Dunedin, New Zealand
name: Rohit Jain, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Blis Technologies Ltd, Dunedin, New Zealand
name: John R Tagg, 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.
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.
citation: 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.