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Probiotic Toothpaste for Microbial Colonization

NCT ID: NCT05480020

Last Updated: 2022-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-31

Study Completion Date

2022-10-31

Brief Summary

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

Detailed Description

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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

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Microbial Colonization

Keywords

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Probiotic toothpaste, Streptococcus salivarius M18, microbial colonization, oral probiotic, toothpaste

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants
A staff member not part of the study group will be assigned to distribute blinded samples. The participant or the investigators will not be aware of the dose groups.

Study Groups

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Streptococcus salivarius M18 toothpaste dose 1

Streptococcus salivarius M18 toothpaste containing 1 million cfu/g

Group Type ACTIVE_COMPARATOR

Streptococcus salivarius M18 toothpaste

Intervention Type OTHER

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 toothpaste dose 2

Streptococcus salivarius M18 toothpaste containing 10 million cfu/g

Group Type ACTIVE_COMPARATOR

Streptococcus salivarius M18 toothpaste

Intervention Type OTHER

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 toothpaste dose 3

Streptococcus salivarius M18 toothpaste containing 100 million cfu/g

Group Type ACTIVE_COMPARATOR

Streptococcus salivarius M18 toothpaste

Intervention Type OTHER

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.

Interventions

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Streptococcus salivarius M18 toothpaste

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.

Intervention Type OTHER

Streptococcus salivarius M18 toothpaste

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.

Intervention Type OTHER

Streptococcus salivarius M18 toothpaste

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.

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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John Hale

INDUSTRY

Sponsor Role lead

Responsible Party

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John Hale

CTO

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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John R Tagg, PhD

Role: PRINCIPAL_INVESTIGATOR

Blis Technologies

Rohit Jain, PhD

Role: PRINCIPAL_INVESTIGATOR

Blis Technologies

John D Hale, PhD

Role: PRINCIPAL_INVESTIGATOR

Blis Technologies

Locations

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Blis Technologies Ltd

Dunedin, Otago, New Zealand

Site Status RECRUITING

Countries

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New Zealand

Central Contacts

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John D Hale, PhD

Role: CONTACT

Phone: +6434740988

Email: [email protected]

Rohit Jain, PhD

Role: CONTACT

Phone: +6434740988

Email: [email protected]

Facility Contacts

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John D Hale, PhD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 26491371 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32099975 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23785463 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23449874 (View on PubMed)

Other Identifiers

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BLTCT2022/5

Identifier Type: -

Identifier Source: org_study_id