Recurrent Group A Streptococcus (GAS) infections, primarily presenting as strep throat, are a significant health concern in pediatric populations, leading to symptoms like sore throat, fever, and swollen lymph nodes. GAS is highly contagious and can spread easily among children in close-contact environments like schools and daycare centers, often resulting in frequent re-infections. Managing these recurrent infections typically requires antibiotics, but reliance on antibiotics carries risks, including resistance development, gut microbiota disruption, and various side effects. Probiotic therapy, particularly with Streptococcus salivarius K12, has shown promise as a preventive approach, utilizing competitive exclusion and antimicrobial production to inhibit GAS growth in the oral cavity. Recent studies have advanced this with the development of S. salivarius eK12, a re-engineered strain that enhances efficacy against GAS by preventing the survival-promoting interactions between the probiotic and pathogenic bacteria. This modified strain, now registered as Bactoblis® EVOL in Italy (EU), holds potential as an effective version to reduce the incidence and severity of GAS infections without the drawbacks of antibiotic therapy.
The primary aim of this clinical trial is to evaluate whether prophylactic use of S. salivarius eK12 can effectively reduce the frequency and severity of strep throat episodes in children. By assessing the efficacy of S. salivarius eK12 supplementation, this study seeks to provide insights into its potential as a non-antibiotic preventive strategy for recurrent strep throat infections in pediatric populations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
60
Bactoblis® EVOL: containing one billion CFU of probiotic Streptococcus salivarius eK12
Liaquat University of Medical and Health Sciences
Jamshoro, Pakistan
RECRUITINGRecurrence of Streptococcus pyogenes pharyngotonsillitis infection
Number of episodes of Streptococcus pyogenes pharyngotonsillitis infection
Time frame: 6-months
Probiotic safety and tolerability
Incidences of any side effects
Time frame: 6-months
Protection against viral infection
Number of incidences of viral throat infection
Time frame: 6-months
Protection against Acute Otitis Media infection
Number of incidences of Acute Otitis Media infection
Time frame: 6-months
Protection against respiratory infection
Number of incidences of Tracheitis infection
Time frame: 6-months
Protection against Rhinitis
Number of incidences of Rhinitis
Time frame: 6-months
Protection against flu
Number of incidences of flu
Time frame: 6-months
Protection against Enteritis
Number of incidences of Enteritis infection
Time frame: 6-months
Protection against Stomatitis
Number of incidences of Stomatitis infection
Time frame: 6-months
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