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
About this trial
This is an interventional prevention trial for Rheumatic Fever focused on measuring BLIS K12, streptococcus
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
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
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
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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
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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
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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
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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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Efficacy of BLIS K12 as Preventive Measure for Rheumatic Children
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