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Not yet recruiting NCT07384130

Oral Probiotics for Halitosis in Healthy Adults

No phase Interventional Halitosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 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.
Who it may be relevant to
Registry conditions: Halitosis. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
New Zealand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Efficacy of Oral Probiotics on Cysteine-Induced Halitosis in Healthy Adult Volunteers.

Overview

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

Detailed description

This is a double-blind, randomized controlled colonization pilot study with no crossover to evaluate the efficacy of probiotic lozenges on halitosis in healthy adults.

Participants will be randomly assigned to 2 groups consuming probiotic lozenge containing Streptococcus salivarius M18 and K12 and with prebiotic over a 13 day period. Breath scores will be measured at predetermined time points pre and post intervention.

Interventions

  • 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
    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.
  • Other Placebo
    Probiotic free placebo lozenge

Primary outcome measures

  • Measurement of Volatile Sulphur Compounds in ppb between the active and placebo groups [Time frame: 13 days]

Eligibility criteria

Inclusion criteria

  • Participants should be otherwise healthy,
  • practice good oral hygiene,
  • 18 - 70 years of age

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Basic science

Study locations

New Zealand · 1 center
  • Blis Technologies Ltd — Dunedin

Publications

  • 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 23449874

Identifiers

NCT: NCT07384130 · BLTCT2025/1 · 2025EXP24497

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗