Clinical trial NCT05480020: Probiotic Toothpaste for Microbial Colonization
Official title: Colonisation Efficacy of Streptococcus Salivarius M18 Toothpaste
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Microbial Colonization
Keywords: Probiotic toothpaste, Streptococcus salivarius M18, microbial colonization, oral probiotic, toothpaste
Lead sponsor: BLIS Technologies Limited
Sponsor class: INDUSTRY
First posted: 2022-07-29
Enrollment: 30
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 3 groups for brushing teeth with a probiotic toothpaste containing different doses of Streptococcus salivarius M18 Study Group A: BLIS M18 Toothpaste (1 Million Cfu/dose) (n = 10) Study Group B: BLIS M18 Toothpaste (10 Million Cfu/dose) (n = 10) Study Group C: BLIS M18 Toothpaste (100 Million Cfu/dose) (n = 10)
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to evaluate the colonization efficacy of probiotic toothpastes in healthy adults

Detailed description: This is a double blind randomized controlled study with no cross over to evaluate the colonization efficacy of toothpaste containing a commercially available probiotic bacterium Streptococcus salivarius M18.

Participants will be randomly assigned to one of the 3 groups for brushing teeth with a probiotic toothpaste containing different doses of Streptococcus salivarius M18 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:

* In general good health
* Practise 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 hour 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 24 hours post last dose
timeFrame: 24 hours after last dose following 7 days of daily brushing with probiotic toothpaste.
Secondary outcomes:
Other outcomes:
Locations:
city: Dunedin
country: New Zealand
facility: Blis Technologies Ltd
state: Otago
Study officials:
affiliation: Blis Technologies
name: John R Tagg, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Blis Technologies
name: Rohit Jain, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Blis Technologies
name: John D Hale, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Burton JP, Wescombe PA, Macklaim JM, Chai MH, Macdonald K, Hale JD, Tagg J, Reid G, Gloor GB, Cadieux PA. Persistence of the oral probiotic Streptococcus salivarius M18 is dose dependent and megaplasmid transfer can augment their bacteriocin production and adhesion characteristics. PLoS One. 2013 Jun 13;8(6):e65991. doi: 10.1371/journal.pone.0065991. Print 2013.
citation: Burton JP, Drummond BK, Chilcott CN, Tagg JR, Thomson WM, Hale JDF, Wescombe PA. Influence of the probiotic Streptococcus salivarius strain M18 on indices of dental health in children: a randomized double-blind, placebo-controlled trial. J Med Microbiol. 2013 Jun;62(Pt 6):875-884. doi: 10.1099/jmm.0.056663-0. Epub 2013 Feb 28.