Rheumatic FeverNCT02407106
Efficacy of BLIS K12 as Preventive Measure for Rheumatic Children
A study testing Streptococcus Salivarius BLIS K12 in people with Rheumatic Fever, run by Kaplan Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Rheumatic Fever
- What is being tested?
- Streptococcus Salivarius BLIS K12
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Rheumatic heart disease with recommended strep prophylaxis
Who cannot join
- less than one year from first diagnosis
- refusal to take the tablets
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy of Streptococcus Salivarius BLIS (Bacteriocin-like Inhibitory Substance) K12 as Preventive Measure for Rheumatic Children.
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.
Read the 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.
- Conditions
- Rheumatic Fever
- Being tested
- Streptococcus Salivarius BLIS K12
- Keywords
- BLIS K12, streptococcus
- Medical subject headings
- Rheumatic Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Streptococcus Salivarius BLIS K12Dietary supplement
Also called Bio-BLIS
Once daily tablet of BLIS K 12 to be slowly dissolved orally every evening.
| Study group | Role | What they receive |
|---|---|---|
| BLIS K12 treatment | Experimental | Once daily tablet of Streptococcus Salivarius BLIS K 12 to be slowly dissolved orally every evening for six month Receives: Dietary Supplement: Streptococcus Salivarius BLIS K12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of Strep throat infections while in study
Measured: six month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Rheumatic FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaplan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Yael Garty MD, Kaplan Medical Center
- Investigators
- Yael Garty, MD, Principal investigator, Attending physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02407106
- Sponsor's protocol ID
- 027-15-KMC
- Status last verified
- Apr 2015
- First submitted
- 30 Mar 2015
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
May G, Wilson MG, Lubschez R. Recurrence rates in rheumatic fever. JAMA. 1944, Vol. 126, 8, pp. 477-480.
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.
PubMed 4254612FEINSTEIN 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.
PubMed 13644570Lue 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.
PubMed 3511209John 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.
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.
PubMed 23045482J. 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.
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.
PubMed 16461700Di 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.
PubMed 24600248Burton 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.
PubMed 26781236Burton 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.
PubMed 21722694Di 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.
PubMed 23233809
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Streptococcus Salivarius BLIS (Bacteriocin-like Inhibitory Substance) K12 as Preventive Measure for Rheumatic Children.
- ClinicalTrials.gov ID
- NCT02407106
- Acronym / sponsor ID
- 027-15-KMC
- Conditions
- Rheumatic Fever
- Keywords
- BLIS K12, streptococcus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kaplan Medical CenterUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Mar 2016 (estimated)
- First posted
- 2 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BLIS K12 treatment | Experimental | Dietary Supplement: Streptococcus Salivarius BLIS K12Once daily tablet of Streptococcus Salivarius BLIS K 12 to be slowly dissolved orally every evening for six month |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Rheumatic heart disease with recommended strep prophylaxis
Key exclusion criteria (2 listed)
- less than one year from first diagnosis
- refusal to take the tablets
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Streptococcus Salivarius BLIS K12Also: Bio-BLISOnce daily tablet of BLIS K 12 to be slowly dissolved orally every evening. | Dietary supplement | BLIS K12 treatment |
Primary outcome
number of Strep throat infections while in study
Time frame: six month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2015.
- BackgroundMay G, Wilson MG, Lubschez R. Recurrence rates in rheumatic fever. JAMA. 1944, Vol. 126, 8, pp. 477-480.
- Background: PubMed 4254612Spagnuolo 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.
- Background: PubMed 13644570FEINSTEIN 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.
- Background: PubMed 3511209Lue 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.
- BackgroundJohn 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: PubMed 23045482Barretto 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.
- BackgroundJ. 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: PubMed 16461700Wescombe 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.
- Background: PubMed 24600248Di 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.
- Background: PubMed 26781236Burton 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.
- Background: PubMed 21722694Burton 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.
- Background: PubMed 23233809Di 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yael Garty, MD principal investigator
Attending physician
Questions about this trial
What is this clinical trial studying?
A study testing Streptococcus Salivarius BLIS K12 in people with Rheumatic Fever, run by Kaplan Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yael Garty, MD (+972-52-3413184, yaelga@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of Strep throat infections while in study (time frame: six month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02407106, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2015.