Probiotic Intervention to reduce streptococcal disease burden in New Zealand Children

Placebo controlled trial of the effect of BLIS probiotic, S salivarius (K12) on culture positive S pyogenes pharyngitis amongst 5-14 year old children

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615001076561

Enrollment

1200

Registered

2015-10-13

Start date

2014-08-04

Completion date

2015-02-27

Last updated

2020-01-13

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

Conditions

None listed

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

Interventions

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

Study design

Allocation

Non-randomised trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

5 Years to 14 Years

Healthy volunteers

Yes

Inclusion criteria

All children currently enrolled in Ministry of Health throat swabbing and treatment programme in East Porirua

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

Outcome results