Rheumatic Fever Clinical Trial
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.
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03281863 -
Clinical Audit on the Managment in Assiut University Children Hospital
|
||
| Not yet recruiting |
NCT06259006 -
TREAT-SC: Early, Short Course Oral Dexamethasone for the Treatment of Sydenham Chorea in Children
|
Phase 3 | |
| Withdrawn |
NCT03998592 -
Clinical Trial to Assess Safety and Immunogenicity of a Synthetic Vaccine Against Streptococcus Pyogenes
|
Phase 1 | |
| Recruiting |
NCT04316897 -
Prevalence of Rheumatic Heart Disease According to Revised Jones Criteria (2015) in Assiut Governate
|
||
| Completed |
NCT04798053 -
Impact of COVID-19 Pandemic and Social Distancing on Mental Health of Chronic Inflammatory Rheumatism Affected Patients
|
N/A | |
| Completed |
NCT02124109 -
The Genetic Basis of Acquired Heart Disease in Africa
|