NCT02407106

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 2, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Last Updated

April 3, 2015

Status Verified

April 1, 2015

Enrollment Period

6 months

First QC Date

March 30, 2015

Last Update Submit

April 2, 2015

Conditions

Rheumatic Fever

Keywords

BLIS K12streptococcus

Outcome Measures

Primary Outcomes (1)

  • number of Strep throat infections while in study

    six month

Study Arms (1)

BLIS K12 treatment

EXPERIMENTAL

Once daily tablet of Streptococcus Salivarius BLIS K 12 to be slowly dissolved orally every evening for six month

Dietary Supplement: Streptococcus Salivarius BLIS K12

Interventions

Streptococcus Salivarius BLIS K12DIETARY_SUPPLEMENT

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

Also known as: Bio-BLIS
BLIS K12 treatment

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Rheumatic heart disease with recommended strep prophylaxis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

  • May G, Wilson MG, Lubschez R. Recurrence rates in rheumatic fever. JAMA. 1944, Vol. 126, 8, pp. 477-480.

    BACKGROUND

  • Spagnuolo M, Pasternack B, Taranta A. Risk of rheumatic-fever recurrences after streptococcal infections. Prospective study of clinical and social factors. N Engl J Med. 1971 Sep 16;285(12):641-7. doi: 10.1056/NEJM197109162851201. No abstract available.

    PMID: 4254612BACKGROUND

  • FEINSTEIN AR, WOOD HF, EPSTEIN JA, TARANTA A, SIMPSON R, TURSKY E. A controlled study of three methods of prophylaxis against streptococcal infection in a population of rheumatic children. II. Results of the first three years of the study, including methods for evaluating the maintenance of oral prophylaxis. N Engl J Med. 1959 Apr 2;260(14):697-702. doi: 10.1056/NEJM195904022601405. No abstract available.

    PMID: 13644570BACKGROUND

  • Lue HC, Wu MH, Hsieh KH, Lin GJ, Hsieh RP, Chiou JF. Rheumatic fever recurrences: controlled study of 3-week versus 4-week benzathine penicillin prevention programs. J Pediatr. 1986 Feb;108(2):299-304. doi: 10.1016/s0022-3476(86)81009-5.

    PMID: 3511209BACKGROUND

  • John D.F. Hale, John R. Tagg, and Philip A. Wescombe. BLIS-producing probiotics targeting the oral cavity. Microbiology Australia. 2012, Vol. 33, 3, pp. 103-105.

    BACKGROUND

  • Barretto C, Alvarez-Martin P, Foata F, Renault P, Berger B. Genome sequence of the lantibiotic bacteriocin producer Streptococcus salivarius strain K12. J Bacteriol. 2012 Nov;194(21):5959-60. doi: 10.1128/JB.01268-12.

    PMID: 23045482BACKGROUND

  • J. Tagg, P. Wescombe , J. Burton. Oral streptococcal BLIS: Heterogeneity of the effector molecules and potential role in the prevention of streptococcal infections. International Congress Series. 2006, Vol. 128, pp. 347-350.

    BACKGROUND

  • Wescombe PA, Upton M, Dierksen KP, Ragland NL, Sivabalan S, Wirawan RE, Inglis MA, Moore CJ, Walker GV, Chilcott CN, Jenkinson HF, Tagg JR. Production of the lantibiotic salivaricin A and its variants by oral streptococci and use of a specific induction assay to detect their presence in human saliva. Appl Environ Microbiol. 2006 Feb;72(2):1459-66. doi: 10.1128/AEM.72.2.1459-1466.2006.

    PMID: 16461700BACKGROUND

  • Di Pierro F, Colombo M, Zanvit A, Risso P, Rottoli AS. Use of Streptococcus salivarius K12 in the prevention of streptococcal and viral pharyngotonsillitis in children. Drug Healthc Patient Saf. 2014 Feb 13;6:15-20. doi: 10.2147/DHPS.S59665. eCollection 2014.

    PMID: 24600248BACKGROUND

  • Burton JP, Chilcott CN, Wescombe PA, Tagg JR. Extended Safety Data for the Oral Cavity Probiotic Streptococcus salivarius K12. Probiotics Antimicrob Proteins. 2010 Oct;2(3):135-44. doi: 10.1007/s12602-010-9045-4.

    PMID: 26781236BACKGROUND

  • Burton JP, Cowley S, Simon RR, McKinney J, Wescombe PA, Tagg JR. Evaluation of safety and human tolerance of the oral probiotic Streptococcus salivarius K12: a randomized, placebo-controlled, double-blind study. Food Chem Toxicol. 2011 Sep;49(9):2356-64. doi: 10.1016/j.fct.2011.06.038. Epub 2011 Jun 21.

    PMID: 21722694BACKGROUND

  • Di Pierro F, Donato G, Fomia F, Adami T, Careddu D, Cassandro C, Albera R. Preliminary pediatric clinical evaluation of the oral probiotic Streptococcus salivarius K12 in preventing recurrent pharyngitis and/or tonsillitis caused by Streptococcus pyogenes and recurrent acute otitis media. Int J Gen Med. 2012;5:991-7. doi: 10.2147/IJGM.S38859. Epub 2012 Nov 30.

    PMID: 23233809BACKGROUND

MeSH Terms

Conditions

Rheumatic Fever

Condition Hierarchy (Ancestors)

Streptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Yael Garty, MD

    Attending physician

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yael Garty, MD

CONTACT

+972-52-3413184yaelga@clalit.org.il

Ofra Goldzweig, MD

CONTACT

+972-50-5525538ofragol@clalit.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 30, 2015

First Posted

April 2, 2015

Study Start

September 1, 2015

Primary Completion

March 1, 2016

Last Updated

April 3, 2015

Record last verified: 2015-04