Clinical trial NCT05375396: Microbial Colonization of Dairy Free Oral Probiotics
Official title: Assessment of Colonization of Dairy Free Probiotic Bacterium Streptococcus Salivarius From Lozenges to the Oral Cavity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Microbial Colonization
Keywords: Streptococcus salivarius M18
dairy free
allergen free
probiotic
microbial colonization
oral probiotic
chewable tablet
Lead sponsor: BLIS Technologies Limited
Sponsor class: INDUSTRY
First posted: 2022-05-16
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: Probiotic Streptococcus salivarius M18 lozenges Probiotics dairy free Streptococcus salivarius M18 lozenges
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to evaluate the colonization efficacy of probiotic lozenges containing dairy and dairy free probiotic Streptococcus salivarius M18, 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 two different lozenges containing either dairy or dairy free probiotic bacteria Streptococcus salivarius M18.

Participants will be randomly assigned to one of the 2 groups consuming probiotic lozenge containing dairy free Streptococcus salivarius M18 or dairy based 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:

Male or Female 18y - 80y age

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 of S. salivarius M18 from Day 0 (baseline) to 1 hour
timeFrame: 1 hour post intervention
measure: Change in microbial colonization of S. salivarius M18 from Day 0 (baseline) to 8 hours
timeFrame: 8 hour post intervention
measure: Change in microbial colonization of S. salivarius M18 from Day 0 (baseline) to 24 hours
timeFrame: 24 hours post intervention
measure: Change in microbial colonization of S. salivarius M18 from Day 0 (baseline) to 48hours
timeFrame: 48 hours post intervention
measure: Change in microbial colonization of dairy free S. salivarius M18 from Day 0 (baseline) to 1 hour
timeFrame: 1 hour post intervention
measure: Change in microbial colonization of dairy free S. salivarius M18 from Day 0 (baseline) to 8 hour
timeFrame: 8 hour post intervention
measure: Change in microbial colonization of dairy free S. salivarius M18 from Day 0 (baseline) to 24 hour
timeFrame: 24 hour post intervention
measure: Change in microbial colonization of dairy free S. salivarius M18 from Day 0 (baseline) to 48 hour
timeFrame: 48 hour post intervention
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 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: STUDY_DIRECTOR
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.