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Efficacy of BLIS K12 as Preventive Measure for Rheumatic Children

Primary Purpose

Rheumatic Fever

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Streptococcus Salivarius BLIS K12
Sponsored by
Kaplan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rheumatic Fever focused on measuring BLIS K12, streptococcus

Eligibility Criteria

6 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Rheumatic heart disease with recommended strep prophylaxis

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    BLIS K12 treatment

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    number of Strep throat infections while in study

    Secondary Outcome Measures

    Full Information

    First Posted
    March 30, 2015
    Last Updated
    April 2, 2015
    Sponsor
    Kaplan Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02407106
    Brief Title
    Efficacy of BLIS K12 as Preventive Measure for Rheumatic Children
    Official Title
    Efficacy of Streptococcus Salivarius BLIS (Bacteriocin-like Inhibitory Substance) K12 as Preventive Measure for Rheumatic Children.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2015 (undefined)
    Primary Completion Date
    March 2016 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kaplan Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rheumatic Fever
    Keywords
    BLIS K12, streptococcus

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    BLIS K12 treatment
    Arm Type
    Experimental
    Arm Description
    Once daily tablet of Streptococcus Salivarius BLIS K 12 to be slowly dissolved orally every evening for six month
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Streptococcus Salivarius BLIS K12
    Other Intervention Name(s)
    Bio-BLIS
    Intervention Description
    Once daily tablet of BLIS K 12 to be slowly dissolved orally every evening.
    Primary Outcome Measure Information:
    Title
    number of Strep throat infections while in study
    Time Frame
    six month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Rheumatic heart disease with recommended strep prophylaxis Exclusion Criteria: less than one year from first diagnosis refusal to take the tablets
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yael Garty, MD
    Phone
    +972-52-3413184
    Email
    yaelga@clalit.org.il
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ofra Goldzweig, MD
    Phone
    +972-50-5525538
    Email
    ofragol@clalit.org.il
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yael Garty, MD
    Organizational Affiliation
    Attending physician
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    Citation
    May G, Wilson MG, Lubschez R. Recurrence rates in rheumatic fever. JAMA. 1944, Vol. 126, 8, pp. 477-480.
    Results Reference
    background
    PubMed Identifier
    4254612
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    13644570
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    3511209
    Citation
    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.
    Results Reference
    background
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23045482
    Citation
    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.
    Results Reference
    background
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    16461700
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    24600248
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    26781236
    Citation
    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.
    Results Reference
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    PubMed Identifier
    21722694
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23233809
    Citation
    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.
    Results Reference
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