Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001076561
Ethics application status
Approved
Date submitted
13/08/2014
Date registered
13/10/2015
Date last updated
13/10/2015
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)
U111111519601
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

Intervention/exposure
Study type
Interventional
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
Prevention
Comparator / control treatment
Identical placebo
Control group
Placebo

Outcomes
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

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
Yes
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
Prevention
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
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
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
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
4/08/2014
Date of last participant enrolment
Anticipated
Actual
27/02/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
1600
Accrual to date
Final
1200
Recruitment outside Australia
Country [1] 6292 0
New Zealand
State/province [1] 6292 0
Porirua

Funding & Sponsors
Funding source category [1] 289766 0
Government body
Name [1] 289766 0
Health Research Council
Country [1] 289766 0
New Zealand
Primary sponsor type
University
Name
University of Otago, Wellington
Address
23a Mein St
Newtown
Wellington 6021
NZ
Country
New Zealand
Secondary sponsor category [1] 288456 0
None
Name [1] 288456 0
Address [1] 288456 0
Country [1] 288456 0

Ethics approval
Ethics application status
Approved
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
Wellington
6011
Ethics committee country [1] 291496 0
New Zealand
Date submitted for ethics approval [1] 291496 0
25/04/2014
Approval date [1] 291496 0
14/05/2014
Ethics approval number [1] 291496 0
14/CEN/10

Summary
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

Contacts
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
julian.crane@otago.ac.nz
Contact person for public queries
Name 49103 0
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
julian.crane@otago.ac.nz
Contact person for scientific queries
Name 49104 0
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
julian.crane@otago.ac.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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