NCT07384130

Brief Summary

The aim of this study is to evaluate efficacy of a probiotic lozenge containing BLIS M18, BLIS K12 and a prebiotic in healthy adults.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress44%
Mar 2026Jul 2026

First Submitted

Initial submission to the registry

January 25, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 3, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

March 15, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2026

Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

January 25, 2026

Last Update Submit

February 2, 2026

Conditions

Halitosis

Keywords

oral probiotichalitosisStreptococcus salivarius M18Streptococcus salivarius K12chewable tablet

Outcome Measures

Primary Outcomes (1)

  • Measurement of Volatile Sulphur Compounds in ppb between the active and placebo groups

    Study will determine the change in Volatile Sulphur Compounds (VSCs) as measured in ppb, following application of probiotic lozenges containing Streptococcus salivarius K12, Streptococcus salivarius M18 and prebiotic compared with a placebo lozenge. Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to post cysteine mouthrinse before the lozenge application and 13 days after once a day lozenge application with the level of significance of p≤0.05 across the probiotic and placebo lozenge. Appropriate statistical analysis software (e.g. Microsoft Excel) will be used to analyse the data

    13 days

Study Arms (2)

Oral probiotic lozenges

ACTIVE COMPARATOR

Oral probiotic lozenges containing Streptococcus salivarius M18 and Streptococcus salivarius K12 and prebiotic

Dietary Supplement: In this study, a probiotic lozenge formulation containing S. salivarius K12, M18 and prebiotic will be evaluated for its potential to improve bad breath

Placebo lozenges

PLACEBO COMPARATOR

Oral lozenges

Other: Placebo

Interventions

In this study, a probiotic lozenge formulation containing S. salivarius K12, M18 and prebiotic will be evaluated for its potential to improve bad breathDIETARY_SUPPLEMENT

In this study, a probiotic-free lozenge formulation containing S. salivarius K12, M18 and prebiotic will be evaluated for its potential to improve bad breath as a comparator.

Oral probiotic lozenges
PlaceboOTHER

Probiotic free placebo lozenge

Placebo lozenges

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants should be otherwise healthy,
  • practice good oral hygiene,
  • years of age

You may not qualify if:

  • on antibiotic therapy,
  • immunocompromised (have a weakened immune system)
  • history of autoimmune disease,
  • allergy or sensitivity to dairy,
  • have an active periodontal disease, any known allergy or sensitivity to components of the test product or cysteine solution.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Blis Technologies Ltd

Dunedin, Otago, 9012, New Zealand

Location

Related Publications (1)

  • 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.

    PMID: 23449874BACKGROUND

MeSH Terms

Conditions

Halitosis

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • John R Tagg, PhD

    BLIS Technologies Ltd

    PRINCIPAL INVESTIGATOR

Central Study Contacts

John D Hale, PhD

CONTACT

+6434740988john.hale@blis.co.nz

Rohit Jain, PhD

CONTACT

+6434740988rohit.jain@blis.co.nz

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
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.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief Technology Officer

Study Record Dates

First Submitted

January 25, 2026

First Posted

February 3, 2026

Study Start

March 15, 2026

Primary Completion (Estimated)

June 15, 2026

Study Completion (Estimated)

July 15, 2026

Last Updated

February 4, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

Data and information included in the Protocol and Clinical Study Report will be shared to other researchers and/or in publications in due course.

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
Study report 3 months after the completion of the study
Access Criteria
Summary study report will be shared by Principal Investigator upon request if not published in public literature

Locations

NZ(1)