ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617000710325

Ethics application status

Approved

Date submitted

10/05/2017

Date registered

17/05/2017

Date last updated

5/07/2021

Date data sharing statement initially provided

8/04/2019

Date results provided

8/04/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

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

Scientific title

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

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1183-1833

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Head and neck cancer

Condition category

Condition code

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Cancer

Head and neck

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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.

Intervention code [1]

Treatment: Other

Intervention code [2]

Prevention

Comparator / control treatment

Placebo controlled study.
BLIS M18 lozenge ingredients: Isomalt, Tableting Aids, Streptococcus salivarius M18 (contains at least 2.50 billion cfu/ dose at the date of manufacture), Strawberry Flavour.
Placebo: as per BLIS M18 lozenge; Streptococcus salivarius M18 excluded

Control group

Placebo

Outcomes

Primary outcome [1]

Microbiological changes: 16S rRNA sequencing of the DNA extracted from the probiotic lozenges will be use to study changes in abundance of S. salivarius.
No samples were analysed and the change was made after recruitment was completed.

Timepoint [1]

Pre-intervention, four weeks post BLIS intervention commencement.

Primary outcome [2]

Microbiological changes: Changes in the diversity of oral bacterial communities based on Illumina sequencing of the 16S rRNA gene

Timepoint [2]

Pre-intervention, four weeks post BLIS intervention commencement.

Secondary outcome [1]

Periodontal health: will be assessed using a periodontal probe to determine Community Periodontal Index of Treatment Need (CPITN) scores

Timepoint [1]

Pre-intervention, four weeks post BLIS intervention commencement.

Secondary outcome [2]

Periodontal health: Silness-Loe Plaque Index scores

Timepoint [2]

Pre-intervention, four weeks post BLIS intervention commencement.

Secondary outcome [3]

Microbiological changes: Changes in the predicted function of oral bacterial communities based on Illumina sequencing of the 16S rRNA gene

Timepoint [3]

Pre-intervention, four weeks post BLIS intervention commencement.

Eligibility

Key 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

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

No

Key exclusion criteria

Edentulous, palliative care

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Lettered containers. Allocation will be recorded.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Block randomisation

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

The people assessing the outcomes

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

5/06/2017

Actual

6/11/2017

Date of last participant enrolment

Anticipated

30/04/2018

Actual

31/10/2018

Date of last data collection

Anticipated

28/05/2018

Actual

28/11/2018

Sample size

Target

20

Accrual to date

Final

17

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

University

Name [1]

The University of Auckland

Address [1]

The University of Auckland
Private Bag 92019
Auckland 1142

Country [1]

New Zealand

Primary sponsor type

University

Name

The University of Auckland

Address

The University of Auckland
Private Bag 92019
Auckland 1142

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Health and Disability Ethics Committees

Ethics committee address [1]

Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

04/08/2016

Approval date [1]

24/08/2016

Ethics approval number [1]

16/STH/123

Ethics committee name [2]

ADHB Research Review Committee

Ethics committee address [2]

Auckland DHB
Research Office
Level 14, Support Building
Auckland City Hospital
Private Bag 92024
Grafton
Auckland 1023

Ethics committee country [2]

New Zealand

Date submitted for ethics approval [2]

09/06/2016

Approval date [2]

10/05/2017

Ethics approval number [2]

A+7396

Summary

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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Richard Douglas

Address

Department of Surgery (University of Auckland)
12th Floor Support Building
Auckland City Hospital
Grafton
Auckland 1142

Country

New Zealand

Phone

+64 9 923 1658

Fax

Email

richard.douglas@auckland.ac.nz

Contact person for public queries

Name

Kim Gear

Address

Oral Health Unit (Auckland District Health Board)
Green Lane Clinical Centre
214 Green Lane West
Epsom
Auckland 1051

Country

New Zealand

Phone

+64 9 630 9809

Fax

Email

KGear@adhb.govt.nz

Contact person for scientific queries

Name

Mike Taylor

Address

School of Biological Sciences
University of Auckland
Private Bag 92019
Auckland 1142

Country

New Zealand

Phone

+64 9 923 2280

Fax

Email

mw.taylor@auckland.ac.nz

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

Patient demographics and individual participant clinical data collected during the trial, after de-identification.

When will data be available (start and end dates)?

Immediately following publication. The study was published in August 2020, meaning that data was available from 6th August 2020 - indefinitely.

Available to whom?

Published in an open access journal.

Available for what types of analyses?

To achieve the aims in the approved proposal.

How or where can data be obtained?

The datasets analysed during this study are available in the NCBI Sequence Read Archive (https://www.ncbi.nlm.nih.gov/sra) under Accession Number PRJNA588128.

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.