Skip to content

Randomised clinical trial of the probiotic BLIS M18 (Streptococcus salivarius) on the post-radiotherapy oral microbiome and periodontal health

Randomised clinical trial of the probiotic BLIS M18 (Streptococcus salivarius) on the post-radiotherapy oral microbiome and periodontal health in adults with a history of head and neck cancer

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000710325
Enrollment
17
Registered
2017-05-17
Start date
2017-11-06
Completion date
2018-10-31
Last updated
2021-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Radiotherapy to the head and neck region permanently damages salivary glands, resulting in a decrease in salivary flow that manifests as a dry mouth. Post-radiotherapy, head and neck cancer patients suffer long-term changes to the oral environment, including a reduction in salivary flow that results in a loss of salivary buffering capacity. Ultimately, an increase in bacterial load and alteration of the bacterial community structure potentially have negative effects on the patient’s oral health. Oral probiotics have been successfully shown to improve oral health, particularly in terms of reducing periodontal inflammation. The benefits of gut probiotics are well documented and include modulation of immune responses and metabolic effect – therefore, the potential mechanisms of oral probiotic action are hypothesised to be similar to those seen in the intestines: antagonism against pathogens and the reduction of inflammation and tissue destruction. Hence, this pilot study proposes that the provision of Streptococcus salivarius in the form of an oral probiotic (BLIS M18) post-radiotherapy treatment may favorably alter the composition of the oral microbial community, reducing periodontal inflammation and improving oral health.

Interventions

BLIS M18 (BLIS Technologies, Dunedin, New Zealand), a lozenge containing 2.5 X 10^9 cfu per lozenge (at the time of manufacture) of the bacterial oral probiotic Streptococcus salivarius. One lozenge daily for one month. Patients will be asked to return any unused lozenges when they attend the final appointment.

Sponsors

The University of Auckland
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Dentate (at least 50% of own teeth present), received radiotherapy to the head and neck region (at least 60 Gy) completed or to be completed within 7 days

Exclusion criteria

Edentulous, palliative care

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026