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Efficacy of BLIS K12 as Preventive Measure for Rheumatic Children

Efficacy of Streptococcus Salivarius BLIS (Bacteriocin-like Inhibitory Substance) K12 as Preventive Measure for Rheumatic Children.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02407106
Enrollment
30
Registered
2015-04-02
Start date
2015-09-30
Completion date
Unknown
Last updated
2015-04-03

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

Conditions

Rheumatic Fever

Keywords

BLIS K12, streptococcus

Brief summary

The purpose of this study is to determine whether daily treatment with Streptococcus Salivarius BLIS K-12 prevents streptococcal throat infection in children that have had an episode of rheumatic fever.

Detailed description

Children diagnosed with Rheumatic fever are currently given preventive streptococcal treatment with either monthly IM (intramuscular injection) Penicillin or daily oral Penicillin. This preventive treatment is recommended for years until the child is 20 y old or even later. The compliance rate for this treatment declines significantly with time (the injections are painful) and even with good adherence the prevention is not complete. In the last few years a new product licensed as BLIS K-12 has been developed and approved by FDA as GRAS (generally recognized as safe) status from 2011. This probiotic treatment prevents the pathogenic Strep A from adhering to the throat of the child thus preventing the infection. This kind of prevention is better for the long run for the patient and for the surrounding, It is better tolerated, is effective even if a dose is skipped or missed is not painful and is tasty to the children. So the investigators assumption is that giving this product to children instead of Penicillin either orally or intramuscularlly will be better tolerated thus give a better protection profile with much less side effects. The investigators will be giving BLIS K-12 to those children on the trial on a daily basis for 6 autumn-winter months instead of Penicillin and will monitor the children by monthly throat swabs. The investigators will also obtain Anti Streptolysin blood test at the end of the period from all participants to evaluate possible Strep encounters.

Interventions

DIETARY_SUPPLEMENTStreptococcus Salivarius BLIS K12

Once daily tablet of BLIS K 12 to be slowly dissolved orally every evening.

Sponsors

Kaplan Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
No

Inclusion criteria

* Rheumatic heart disease with recommended strep prophylaxis

Exclusion criteria

* less than one year from first diagnosis * refusal to take the tablets

Design outcomes

Primary

MeasureTime frame
number of Strep throat infections while in studysix month

Contacts

Primary ContactYael Garty, MD
yaelga@clalit.org.il+972-52-3413184
Backup ContactOfra Goldzweig, MD
ofragol@clalit.org.il+972-50-5525538

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026