Microbial ColonizationNCT05367518
Colonisation Efficacy of Oral Probiotic Fast Melt Powder
A study testing Probiotic Streptococcus salivarius K12 Fast Melt Powder 1 Billion colony forming units /g) and Probiotic Streptococcus salivarius K12 Fast Melt Powder 100 Million colony forming units /g) in people with Microbial Colonization, run by BLIS Technologies Limited at 1 site in New Zealand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Microbial Colonization
- What is being tested?
- Probiotic Streptococcus salivarius K12 Fast Melt Powder 1 Billion colony forming units /g) and Probiotic Streptococcus salivarius K12 Fast Melt Powder 100 Million colony forming units /g)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNew Zealand
- Study dates
- 15 May 2022to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In general good health 18 - 80 years of age.
- Practice good oral hygiene.
Who cannot join
- Have a history of autoimmune disease or are immunocompromised.
- Are on concurrent antibiotic therapy or regular antibiotic use within last 1 week
- History of allergy (e.g. dairy).
Trial locations and contacts
1 site in 1 country.
New Zealand1 site, 1 recruiting
- Recruiting
Blis Technologies Ltd
Dunedin, Otago, 9012
John D Hale, PhD, +6434740988, john.hale@blis.co.nz
Rohit Jain, PhD, +6434740988, rohit.jain@blis.co.nz
About this study
Official title: Assessment of Colonisation of Probiotic Bacterium Streptococcus Salivarius From a Fast Melt Powder Format to the Oral Cavity
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.
Read the 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.
- Conditions
- Microbial Colonization
- Being tested
- Probiotic Streptococcus salivarius K12 Fast Melt Powder 1 Billion colony forming units /g), Probiotic Streptococcus salivarius K12 Fast Melt Powder 100 Million colony forming units /g)
- Keywords
- Streptococcus salivarius K12, Oral Probiotic, Fast Melt Powder
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic Streptococcus salivarius K12 Fast Melt Powder 1 Billion colony forming units /g)Dietary supplement
Probiotic Streptococcus salivarius K12 products are commercially available in traditional formats such as chewable tablet (lozenge) for local delivery in the oral cavity to provide oral health benefits. In this study, a Fast Melt Powder formulation will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity.
Probiotic Streptococcus salivarius K12 Fast Melt Powder 100 Million colony forming units /g)Dietary supplement
Probiotic Streptococcus salivarius K12 products are commercially available in traditional formats such as chewable table (lozenges) for local delivery in the oral cavity to provide oral health benefits. In this study, a Fast Melt Powder formulation will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity.
| Study group | Role | What they receive |
|---|---|---|
| Streptococcus salivarius K12 Fast Melt Powder 1 Billion colony forming units /g | Active comparator | Probiotic Streptococcus salivarius K12 Fast Melt Powder (Dose 1: 1 Billion colony forming units /g) Receives: Dietary Supplement: Probiotic Streptococcus salivarius K12 Fast Melt Powder 1 Billion colony forming units /g) |
| Streptococcus salivarius K12 Fast Melt Powder 100 million colony forming units /g | Active comparator | Group B: Dose 2 Streptococcus salivarius K12 Fast Melt Powder (Dose 2: 100 Million colony forming unit/gram) Receives: Dietary Supplement: Probiotic Streptococcus salivarius K12 Fast Melt Powder 100 Million colony forming units /g) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in microbial colonization from baseline (Day 0) to 1 hour
Study will determine the change in microbial colonization efficacy of two different doses of Streptococcus salivarius K12 in a fast melt powder format. The saliva Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to one hour after later across two different formulations with the level of significance of p≤0.05.Overall colonization based on percentage of population colonized for different interventions will also be analyzed average and standard deviation functions using appropriate statistical analysis software (e.g. Microsoft Excel).
Measured: 1 hours post intervention
Change in microbial colonization from baseline (Day 0) to 8 hours
Study will determine the change in microbial colonization efficacy of two different doses of Streptococcus salivarius K12 in a fast melt powder format. The saliva Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to 8 hours after later across two different formulations with the level of significance of p≤0.05.Overall colonization based on percentage of population colonized for different interventions will also be analyzed average and standard deviation functions using appropriate statistical analysis software (e.g. Microsoft Excel).
Measured: 8 hours post intervention
Change in microbial colonization from baseline (Day 0) to 24 hours
Study will determine the change in microbial colonization efficacy of two different doses of Streptococcus salivarius K12 in a fast melt powder format. The saliva Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to 24 hours after later across two different formulations with the level of significance of p≤0.05.Overall colonization based on percentage of population colonized for different interventions will also be analyzed average and standard deviation functions using appropriate statistical analysis software (e.g. Microsoft Excel).
Measured: 24 hours post intervention
Change in microbial colonization from baseline (Day 0) to 48 hours post last dose
Study will determine the change in microbial colonization efficacy of two different doses of Streptococcus salivarius K12 in a fast melt powder format. The saliva Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to 48 hours after last dosing across two different formulations over 7 days, with the level of significance of p≤0.05.Overall colonization based on percentage of population colonized for different interventions will also be analyzed average and standard deviation functions using appropriate statistical analysis software (e.g. Microsoft Excel).
Measured: 48 hours after last dosing following 7 days of daily administration of probiotic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start15 May 2022 (estimated)
- Primary completion25 May 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Microbial ColonizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BLIS Technologies Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John D Hale, PhD, Study director, Blis Technologies Ltd, Dunedin, New ZealandJohn R Tagg, PhD, Principal investigator, Blis Technologies Ltd, Dunedin, New ZealandRohit Jain, PhD, Principal investigator, Blis Technologies Ltd, Dunedin, New Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05367518
- Sponsor's protocol ID
- BLTCT2022/1
- Status last verified
- May 2022
- First submitted
- 3 May 2022
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data and information included in the Protocol and Clinical Study Report will be shared to other researchers and/or in publications in due course.
Publications
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.
PubMed 17194838Burton 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.
PubMed 26781236Gregori 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.
PubMed 26855579Di 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.
PubMed 23286823Di 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.
PubMed 27920580Di 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.
PubMed 27874935
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Colonisation of Probiotic Bacterium Streptococcus Salivarius From a Fast Melt Powder Format to the Oral Cavity
- ClinicalTrials.gov ID
- NCT05367518
- Acronym / sponsor ID
- BLTCT2022/1
- Conditions
- Microbial Colonization
- Keywords
- Streptococcus salivarius K12, Oral Probiotic, Fast Melt Powder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- BLIS Technologies LimitedIndustry (pharma, biotech, devices)
- Study start
- 15 May 2022 (estimated)
- Primary completion
- 25 May 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 10 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Streptococcus salivarius K12 Fast Melt Powder 1 Billion colony forming units /g | Active comparator | Dietary Supplement: Probiotic Streptococcus salivarius K12 Fast Melt Powder 1 Billion colony forming units /g)Probiotic Streptococcus salivarius K12 Fast Melt Powder (Dose 1: 1 Billion colony forming units /g) |
| Streptococcus salivarius K12 Fast Melt Powder 100 million colony forming units /g | Active comparator | Dietary Supplement: Probiotic Streptococcus salivarius K12 Fast Melt Powder 100 Million colony forming units /g)Group B: Dose 2 Streptococcus salivarius K12 Fast Melt Powder (Dose 2: 100 Million colony forming unit/gram) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- In general good health 18 - 80 years of age.
- Practice good oral hygiene.
Key exclusion criteria (3 listed)
- Have a history of autoimmune disease or are immunocompromised.
- Are on concurrent antibiotic therapy or regular antibiotic use within last 1 week
- History of allergy (e.g. dairy).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic Streptococcus salivarius K12 Fast Melt Powder 1 Billion colony forming units /g)Probiotic Streptococcus salivarius K12 products are commercially available in traditional formats such as chewable tablet (lozenge) for local delivery in the oral cavity to provide oral health benefits. In this study, a Fast Melt Powder formulation will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity. | Dietary supplement | Streptococcus salivarius K12 Fast Melt Powder 1 Billion colony forming units /g |
| Probiotic Streptococcus salivarius K12 Fast Melt Powder 100 Million colony forming units /g)Probiotic Streptococcus salivarius K12 products are commercially available in traditional formats such as chewable table (lozenges) for local delivery in the oral cavity to provide oral health benefits. In this study, a Fast Melt Powder formulation will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity. | Dietary supplement | Streptococcus salivarius K12 Fast Melt Powder 100 million colony forming units /g |
Primary outcome
Change in microbial colonization from baseline (Day 0) to 1 hour
Time frame: 1 hours post intervention
Study will determine the change in microbial colonization efficacy of two different doses of Streptococcus salivarius K12 in a fast melt powder format. The saliva Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to one hour after later across two different formulations with the level of significance of p≤0.05.Overall colonization based on percentage of population colonized for different interventions will also be analyzed average and standard deviation functions using appropriate statistical analysis software (e.g. Microsoft Excel).
Change in microbial colonization from baseline (Day 0) to 8 hours
Time frame: 8 hours post intervention
Study will determine the change in microbial colonization efficacy of two different doses of Streptococcus salivarius K12 in a fast melt powder format. The saliva Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to 8 hours after later across two different formulations with the level of significance of p≤0.05.Overall colonization based on percentage of population colonized for different interventions will also be analyzed average and standard deviation functions using appropriate statistical analysis software (e.g. Microsoft Excel).
Change in microbial colonization from baseline (Day 0) to 24 hours
Time frame: 24 hours post intervention
Study will determine the change in microbial colonization efficacy of two different doses of Streptococcus salivarius K12 in a fast melt powder format. The saliva Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to 24 hours after later across two different formulations with the level of significance of p≤0.05.Overall colonization based on percentage of population colonized for different interventions will also be analyzed average and standard deviation functions using appropriate statistical analysis software (e.g. Microsoft Excel).
Change in microbial colonization from baseline (Day 0) to 48 hours post last dose
Time frame: 48 hours after last dosing following 7 days of daily administration of probiotic
Study will determine the change in microbial colonization efficacy of two different doses of Streptococcus salivarius K12 in a fast melt powder format. The saliva Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to 48 hours after last dosing across two different formulations over 7 days, with the level of significance of p≤0.05.Overall colonization based on percentage of population colonized for different interventions will also be analyzed average and standard deviation functions using appropriate statistical analysis software (e.g. Microsoft Excel).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Background: PubMed 17194838Hyink 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.
- Background: PubMed 26781236Burton 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.
- Background: PubMed 26855579Gregori 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.
- Background: PubMed 23286823Di 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.
- Background: PubMed 27920580Di 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.
- Background: PubMed 27874935Di 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.
- Individual participant dataSharing planned: Yes. Data and information included in the Protocol and Clinical Study Report will be shared to other researchers and/or in publications in due course.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John D Hale, PhD study director
Blis Technologies Ltd, Dunedin, New Zealand
John R Tagg, PhD principal investigator
Blis Technologies Ltd, Dunedin, New Zealand
Rohit Jain, PhD principal investigator
Blis Technologies Ltd, Dunedin, New Zealand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic Streptococcus salivarius K12 Fast Melt Powder 1 Billion colony forming units /g) and Probiotic Streptococcus salivarius K12 Fast Melt Powder 100 Million colony forming units /g) in people with Microbial Colonization, run by BLIS Technologies Limited at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John D Hale, PhD (+6434740988, john.hale@blis.co.nz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in microbial colonization from baseline (Day 0) to 1 hour (time frame: 1 hours post intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05367518, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022.