Clinical trial NCT05374070: Antiviral Activity of Oral Probiotics
Official title: Assessment of Anti-viral Activity of Saliva Obtained From Human Volunteers Following Application of Probiotic Streptococcus Salivarius to the Oral Cavity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lower Respiratory Tract Infection
Upper Respiratory Tract Infection
Keywords: Streptococcus salivarius K12
Probiotic
Antiviral activity
Antibacterial activity
microbial colonization
oral probiotic
powder
prebiotic
Lead sponsor: BLIS Technologies Limited
Sponsor class: INDUSTRY
First posted: 2022-05-13
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 4 groups consuming powder containing Streptococcus salivarius K12 or S. salivarius M18 with or without prebiotic:

1. Probiotic Streptococcus salivarius K12 Powder (Dose: 1 Billion cfu/g)
2. Probiotic Streptococcus salivarius K12 Powder with prebiotic (Dose: 1 Billion cfu/g)
3. Probiotic Streptococcus salivarius M18 Powder (Dose: 1 Billion cfu/g)
4. Probiotic Streptococcus salivarius M18 Powder with prebiotic (Dose: 1 Billion cfu/g)
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to test saliva samples obtained from healthy human participants for anti-viral activity after they have consumed S. salivarius probiotic in a powder format.

Detailed description: This is a randomized controlled open pilot study to evaluate saliva samples collected from participants following their consumption of powders containing the commercially marketed probiotic bacterium S. salivarius K12 or S. salivarius M18.

Participants will be randomly assigned to one of the 4 groups consuming probiotic powder containing Streptococcus salivarius K12 or S. salivarius M18 with or without prebiotics (e.g. sugars that may promote probiotic activity). Saliva samples will be collected at predetermined time points pre and post intervention. Antibacterial and Antiviral activity will be determined following established assays. Colonisation 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 antiviral activity following dosing with probiotic S. salivarius K12 in saliva from Day 0 (baseline) to 3 hours
timeFrame: 3 hours post intervention
measure: Change in antiviral activity following dosing with probiotic S. salivarius K12 in saliva from Day 0 (baseline) to 8 hours
timeFrame: 8 hours post intervention
measure: Change in antiviral activity following dosing with probiotic S. salivarius K12 with prebiotic in saliva from Day 0 (baseline) to 3 hours
timeFrame: 3 hours post intervention
measure: Change in antiviral activity following dosing with probiotic S. salivarius K12 with prebiotic in saliva from Day 0 (baseline) to 8 hours
timeFrame: 8 hours post intervention
measure: Change in antiviral activity following dosing with probiotic S. salivarius M18 in saliva from Day 0 (baseline) to 3 hours
timeFrame: 3 hours post intervention
measure: Change in antiviral activity following dosing with probiotic S. salivarius M18 in saliva from Day 0 (baseline) to 8 hours
timeFrame: 8 hours post intervention
measure: Change in antiviral activity following dosing with probiotic S. salivarius M18 with prebiotic in saliva from Day 0 (baseline) to 3 hours
timeFrame: 3 hours post intervention
measure: Change in antiviral activity following dosing with probiotic S. salivarius M18 with prebiotic in saliva from Day 0 (baseline) to 8 hours
timeFrame: 8 hours post intervention
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: Liam Harold, 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.