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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
Probiotic Intervention to reduce streptococcal disease burden in New Zealand Children
Scientific title
Placebo controlled trial of the effect of BLIS probiotic, S salivarius (K12) on culture positive S pyogenes pharyngitis amongst 5-14 year old children
Secondary ID [1] 284768 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
S. pyogenes pharyngitis 292141 0
Condition category
Condition code
Infection 292475 292475 0 0
Studies of infection and infectious agents

Study type
Description of intervention(s) / exposure
Daily S. salivarius probiotic 10^8 cfu's per lozenge. One lozenge daily for 3 school terms during term time. Approx 145 school days. It is not possible to be precise because schools have flexibility over term length and there are 11 schools involved. Lozenges will be administered each day by a school staff member and a record of administration will be kept
Intervention code [1] 290005 0
Comparator / control treatment
Identical placebo
Control group

Primary outcome [1] 292905 0
proportion of children with S pyogenes positive sore throat during treatment period. Measured by standard micro throat swab for GAS
Timepoint [1] 292905 0
proportion during treatment period ie approx 145 days of three school terms
Secondary outcome [1] 309901 0
proportion of children with S. pyogenes carriage at end of trial in treatment versus placebo group. Measured by standard culture of a throat swab for GAS
Timepoint [1] 309901 0
end of treatment period. ie approx 145 days of treatment

Key inclusion criteria
All children currently enrolled in Ministry of Health throat swabbing and treatment programme in East Porirua
Minimum age
5 Years
Maximum age
14 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
1) Children with major heart disease as determined by study investigators. 2) Children with severe immune function impairment as determined by study investigators

Study design
Purpose of the study
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This is a community trial in primary and intermediate schools amongst children who are already enrolled in Ministry of Health programme and who's parents consent to their participation in this trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The only practical method of allocation is to use children's birthday. That is children born on 'even numbered days will receive one treatment. Children born on odd numbered days will receive the alternate treatment
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase 3
Type of endpoint(s)
Statistical methods / analysis
Assuming rate of GAS pharyngitis is 10% during study period With 800 subjects in treatment and placebo arms we will be able to detect a 50% reduction with power 0.97. For 500 subjects per group power 0.82. (alpha 0.05)

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 6292 0
New Zealand
State/province [1] 6292 0

Funding & Sponsors
Funding source category [1] 289766 0
Government body
Name [1] 289766 0
Health Research Council
Address [1] 289766 0
Level 3 - ProCARE Building, Grafton Mews, at 110 Stanley Street, Auckland 1010
Country [1] 289766 0
New Zealand
Primary sponsor type
University of Otago, Wellington
23a Mein St
Wellington 6021
New Zealand
Secondary sponsor category [1] 288456 0
Name [1] 288456 0
Address [1] 288456 0
Country [1] 288456 0

Ethics approval
Ethics application status
Ethics committee name [1] 291496 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 291496 0
1 The Terrace
C/- MEDSAFE, Level 6, Deloitte House
10 Brandon Street
PO Box 5013
Ethics committee country [1] 291496 0
New Zealand
Date submitted for ethics approval [1] 291496 0
Approval date [1] 291496 0
Ethics approval number [1] 291496 0

Brief summary
The study is designed to measure the efficacy of the S. salivarius probiotic to reduce (Group A beta haemolytic strepotoccus) GAS sore throats in high risk children
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 49102 0
Prof Julian Crane
Address 49102 0
Dept of Medicine
School of Medicine, University of Otago
PO Box 7343
Wellington 6021
New Zealand
Country 49102 0
New Zealand
Phone 49102 0
+64 4 918 5258
Fax 49102 0
Email 49102 0
Contact person for public queries
Name 49103 0
Prof Julian Crane
Address 49103 0
Dept of Medicine
School of Medicine, University of Otago
PO Box 7343
Wellington 6021
New Zealand
Country 49103 0
New Zealand
Phone 49103 0
+64 4 918 5258
Fax 49103 0
Email 49103 0
Contact person for scientific queries
Name 49104 0
Prof Julian Crane
Address 49104 0
Dept of Medicine
School of Medicine, University of Otago
PO Box 7343
Wellington 6021
New Zealand
Country 49104 0
New Zealand
Phone 49104 0
+64 4 918 5258
Fax 49104 0
Email 49104 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary