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 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
QUADRUPLE
Enrollment
82
Bactoblis® EVOL: containing one billion CFU of probiotic Streptococcus salivarius eK12
Oral vit D3 tablets (200 IU)
Saboor Clinic
Quetta, Balouchistan, Pakistan
Dr. Khan Afsar ENT Clinic
Haripur, Khyber Pakhtunkhwa, Pakistan
CDF Hospital (Bilawal Medical College, LUMHS)
Hyderābād, Sindh, Pakistan
Dr. Allah Wadhayo Kallo Clinic (Shifa Hurmat Diagnostic and Research Centre)
Hyderābād, Sindh, Pakistan
Recurrence of Streptococcus pyogenes pharyngotonsillitis infection
Number of episodes of Streptococcus pyogenes pharyngotonsillitis infection
Time frame: 6-months
Severity of Group A Streptococcal (GAS) Symptoms
Severity of GAS-associated symptoms assessed using a 10-point Visual Analogue Scale (VAS)
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
Use of Antibiotics
Number of antibiotic courses prescribed during the 6-month study period.
Time frame: 6-months
Persistence of Streptococcus salivarius eK12 in saliva after washout
Post hoc exploratory ancillary analysis, conceived after study completion and unblinding, evaluating the presence of the administered Streptococcus salivarius eK12 strain in saliva at the end of the 6-month study period, approximately 3 months after discontinuation of eK12 supplementation. Saliva samples will be examined using a strain-specific microbiological or molecular method capable of distinguishing eK12 from the parental K12 strain. The outcome will be reported as the proportion of participants with detectable eK12 and, if a validated quantitative method is used, the salivary abundance of eK12. This analysis was not a prespecified outcome of the original clinical trial.
Time frame: Month 6, approximately 3 months after discontinuation of eK12 supplementation.
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