Can one month of Bacteriocin Like Inhibitory Substances BLIS K12 Probiotic with Streptococcus Salivarius taken by Whakatane Primary School children prevent colonization with Group A Streptococcus (GAS) pathogens and decrease GAS Sore throats in this study.

For school pupils at risk of acute rheumatic fever, can one month of probiotic Salivarius BLIS K12 lessen Group A Streptococcal throat carriage and infection?

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000402549

Enrollment

303

Registered

2015-04-30

Start date

2015-06-17

Completion date

2015-06-26

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

We propose to offer a probiotic BLIS K12 to about 500 Whakatane primary school children. In small trials in Italy and Kawerau, NZ it has decreased acute Group A Streptococcal GAS sore throats and recurrent GAS sore throats respectively, both while taken and for many months to follow. Using an open stepped wedge design we will compare GAS colonization and point prevalence of GAS sore throats as our primary outcome measures; The yet to start school rates will be controls for the first month then participants

Interventions

The one month of probiotic Salivarius BLIS K12, the dose will be one tablet daily each with 2 x 10 to the 9th ( 2 x 100,000,000) colony forming units of S. Salivarius K12 plus the lyoprotectant agents trehalose, lactitol and maltodextrin, which are added to enhance the stability and viability of the bacteria. Blis K12 disolves in mouth, and while disolving in mouth is preferred for efficacy, can be swallowed. Adherance will be monitored as the children are school pupils for the 5 weekday

Study design

Allocation

Non-randomised trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

5 Years to 18 Years

Healthy volunteers

Yes

Inclusion criteria

All School pupils of consenting parents at three nominated primary schools

Exclusion criteria

Pupils currently on BLIS K12, the children of non consenting parents, children with significant immunocompromise ( do not anticipate any but screening questions on consent address this possibility )

Outcome results