CompletedPhase 2Phase 3ACTRN12615000402549

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?

Sponsor

Eastern Bay Primary Health Alliance

Enrollment

531 participants

Start Date

Jun 17, 2015

Study Type

Interventional

Conditions

Group A Streptococcal Throat colonization Group A Streptococcal Sore throats

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

Eligibility

Sex: Both males and femalesMin Age: 5 YearssMax Age: 18 Yearss

Inclusion Criteria1

All School pupils of consenting parents at three nominated primary schools

Exclusion Criteria1

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 )

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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 ag

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 weekdays witnessed by teachers and community health workers and observed for 2 days by their parents

Locations(1)

Bay of Plenty, New Zealand

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ACTRN12615000402549