Microbial ColonizationNCT05480020
Probiotic Toothpaste for Microbial Colonization
A study testing Streptococcus salivarius M18 toothpaste in people with Microbial Colonization, run by John Hale at 1 site in New Zealand.
Trial summary
The aim of this study is to evaluate the colonization efficacy of probiotic toothpastes 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?
- Streptococcus salivarius M18 toothpaste
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNew Zealand
- Study dates
- Aug 2022to Oct 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
- Practise 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
About this study
Official title: Colonisation Efficacy of Streptococcus Salivarius M18 Toothpaste
The aim of this study is to evaluate the colonization efficacy of probiotic toothpastes 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 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.
- Conditions
- Microbial Colonization
- Being tested
- Streptococcus salivarius M18 toothpaste
- Keywords
- Probiotic toothpaste, Streptococcus salivarius M18, microbial colonization, oral probiotic, toothpaste
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Streptococcus salivarius M18 toothpasteOther
Probiotics Streptococcus salivarius M18 toothpaste 1 million cfu/g
In this study, a toothpaste formulation containing S. salivarius M18 will be evaluated for its potential for delivering the probiotic to the oral cavity.
Streptococcus salivarius M18 toothpasteOther
Probiotics Streptococcus salivarius M18 toothpaste 10 million cfu/g
In this study, a toothpaste formulation containing S. salivarius M18 will be evaluated for its potential for delivering the probiotic to the oral cavity.
Streptococcus salivarius M18 toothpasteOther
Probiotics Streptococcus salivarius M18 toothpaste 100 million cfu/g
In this study, a toothpaste formulation containing S. salivarius M18 will be evaluated for its potential for delivering the probiotic to the oral cavity.
| Study group | Role | What they receive |
|---|---|---|
| Streptococcus salivarius M18 toothpaste dose 1 | Active comparator | Streptococcus salivarius M18 toothpaste containing 1 million cfu/g Receives: Other: Streptococcus salivarius M18 toothpaste |
| Streptococcus salivarius M18 toothpaste dose 2 | Active comparator | Streptococcus salivarius M18 toothpaste containing 10 million cfu/g Receives: Other: Streptococcus salivarius M18 toothpaste |
| Streptococcus salivarius M18 toothpaste dose 3 | Active comparator | Streptococcus salivarius M18 toothpaste containing 100 million cfu/g Receives: Other: Streptococcus salivarius M18 toothpaste |
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 the microbial colonization efficacy of three different doses of S. salivarius M18 in a toothpaste format.
Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 in a toothpaste format. The saliva Statistical analysis (e.g. ANOVA) will be carried out to compare the participants data from baseline to one hour after later across three 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, GraphPad Prism).
Measured: 1 hour post intervention
Change in Microbial colonization from baseline (Day 0) to 8 hours
Study will determine the change in the microbial colonization efficacy of three different doses of S. salivarius M18 in a toothpaste format.
Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 in a toothpaste format. The saliva Statistical analysis (e.g. ANOVA) will be carried out to compare the participants data from baseline to one hour after later across three 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, GraphPad Prism).
Measured: 8 hours post intervention
Change in Microbial colonization from baseline (Day 0) to 24 hours
Study will determine the change in the microbial colonization efficacy of three different doses of S. salivarius M18 in a toothpaste format.
Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 in a toothpaste format. The saliva Statistical analysis (e.g. ANOVA) will be carried out to compare the participants data from baseline to one hour after later across three 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, GraphPad Prism).
Measured: 24 hours post intervention
Change in Microbial colonization from baseline (Day 0) to 24 hours post last dose
Study will determine the change in the microbial colonization efficacy of three different doses of S. salivarius M18 in a toothpaste format.
Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 in a toothpaste format. The saliva Statistical analysis (e.g. ANOVA) will be carried out to compare the participants data from baseline to one hour after later across three 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, GraphPad Prism).
Measured: 24 hours after last dose following 7 days of daily brushing with probiotic toothpaste.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study startAug 2022 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 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)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- John Hale
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, John Hale, BLIS Technologies Limited
- Investigators
- John R Tagg, PhD, Principal investigator, Blis TechnologiesRohit Jain, PhD, Principal investigator, Blis TechnologiesJohn D Hale, PhD, Principal investigator, Blis Technologies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05480020
- Sponsor's protocol ID
- BLTCT2022/5
- Status last verified
- Jul 2022
- First submitted
- 27 Jul 2022
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26491371Bardellini 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.
PubMed 32099975Burton 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.
PubMed 23785463Burton 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.
PubMed 23449874
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colonisation Efficacy of Streptococcus Salivarius M18 Toothpaste
- ClinicalTrials.gov ID
- NCT05480020
- Acronym / sponsor ID
- BLTCT2022/5
- Conditions
- Microbial Colonization
- Keywords
- Probiotic toothpaste, Streptococcus salivarius M18, microbial colonization, oral probiotic, toothpaste
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- John HaleIndustry (pharma, biotech, devices)
- Study start
- Aug 2022 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 29 Jul 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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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)
| Arm | Type | Receives |
|---|---|---|
| Streptococcus salivarius M18 toothpaste dose 1 | Active comparator | Other: Streptococcus salivarius M18 toothpasteStreptococcus salivarius M18 toothpaste containing 1 million cfu/g |
| Streptococcus salivarius M18 toothpaste dose 2 | Active comparator | Other: Streptococcus salivarius M18 toothpasteStreptococcus salivarius M18 toothpaste containing 10 million cfu/g |
| Streptococcus salivarius M18 toothpaste dose 3 | Active comparator | Other: Streptococcus salivarius M18 toothpasteStreptococcus salivarius M18 toothpaste containing 100 million cfu/g |
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
- Practise 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 |
|---|---|---|
| Streptococcus salivarius M18 toothpasteProbiotics Streptococcus salivarius M18 toothpaste 1 million cfu/g In this study, a toothpaste formulation containing S. salivarius M18 will be evaluated for its potential for delivering the probiotic to the oral cavity. | Other | Streptococcus salivarius M18 toothpaste dose 1 |
| Streptococcus salivarius M18 toothpasteProbiotics Streptococcus salivarius M18 toothpaste 10 million cfu/g In this study, a toothpaste formulation containing S. salivarius M18 will be evaluated for its potential for delivering the probiotic to the oral cavity. | Other | Streptococcus salivarius M18 toothpaste dose 2 |
| Streptococcus salivarius M18 toothpasteProbiotics Streptococcus salivarius M18 toothpaste 100 million cfu/g In this study, a toothpaste formulation containing S. salivarius M18 will be evaluated for its potential for delivering the probiotic to the oral cavity. | Other | Streptococcus salivarius M18 toothpaste dose 3 |
Primary outcome
Change in Microbial colonization from baseline (Day 0) to 1 hour
Time frame: 1 hour post intervention
Study will determine the change in the microbial colonization efficacy of three different doses of S. salivarius M18 in a toothpaste format. Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 in a toothpaste format. The saliva Statistical analysis (e.g. ANOVA) will be carried out to compare the participants data from baseline to one hour after later across three 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, GraphPad Prism).
Change in Microbial colonization from baseline (Day 0) to 8 hours
Time frame: 8 hours post intervention
Study will determine the change in the microbial colonization efficacy of three different doses of S. salivarius M18 in a toothpaste format. Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 in a toothpaste format. The saliva Statistical analysis (e.g. ANOVA) will be carried out to compare the participants data from baseline to one hour after later across three 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, GraphPad Prism).
Change in Microbial colonization from baseline (Day 0) to 24 hours
Time frame: 24 hours post intervention
Study will determine the change in the microbial colonization efficacy of three different doses of S. salivarius M18 in a toothpaste format. Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 in a toothpaste format. The saliva Statistical analysis (e.g. ANOVA) will be carried out to compare the participants data from baseline to one hour after later across three 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, GraphPad Prism).
Change in Microbial colonization from baseline (Day 0) to 24 hours post last dose
Time frame: 24 hours after last dose following 7 days of daily brushing with probiotic toothpaste.
Study will determine the change in the microbial colonization efficacy of three different doses of S. salivarius M18 in a toothpaste format. Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 in a toothpaste format. The saliva Statistical analysis (e.g. ANOVA) will be carried out to compare the participants data from baseline to one hour after later across three 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, GraphPad Prism).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- Background: PubMed 26491371Di 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.
- Background: PubMed 32099975Bardellini 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.
- Background: PubMed 23785463Burton 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.
- Background: PubMed 23449874Burton 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.
- Individual participant dataSharing planned: No
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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 R Tagg, PhD principal investigator
Blis Technologies
Rohit Jain, PhD principal investigator
Blis Technologies
John D Hale, PhD principal investigator
Blis Technologies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Streptococcus salivarius M18 toothpaste in people with Microbial Colonization, run by John Hale 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 29 Jul 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 hour 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 NCT05480020, which also lists 4 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 29 Jul 2022.