Prophylactic Effect of Probiotic Streptococcus Salivarius eK12 Against Recurrent Streptococcus Pyogenes Pharyngotonsillitis Infection in Pediatrics

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.

Inclusion criteria

• Children aged 3-10 years.
• Recent history of documented recurrent episodes of Streptococcus pyogenes pharyngo- tonsillitis infection in the last 6 months, or 4 or more episodes in the last 12 months (S.

pyogenes infection being defined as: McIsaac score with clinical score ≥ 2 plus confirmation of S. pyogenes presence with rapid throat swab (RAD) method or McIsaac score =5.

• Willingness to comply with the study protocol and attend scheduled follow-up visits.
• Written informed consent obtained from the parent or legal guardian.

Exclusion criteria

• Children with known allergies or hypersensitivity to probiotics or any components of the study product.
• Current use of antibiotics or within the past 30 days.
• Used oral colonizing probiotics in the last 6 months.
• Presence of severe underlying medical conditions affecting the immune system or gastrointestinal tract.
• Participation in other clinical trials involving investigational drugs or interventions.
• Inability to adhere to the study requirements due to logistical or social reasons.
• History of rheumatic disorders, bronchospasm, severe asthma, or allergy requiring corticosteroids.
• Past tonsillectomy or an indication for adeno-tonsillectomy; or severe respiratory or systemic disorders
• Individuals immunocompromised or had a condition favouring recurrent Acute Otitis Media (AOM), including severe atopy, acquired or congenital immunodeficiency, cleft palate, craniofacial abnormalities, obstructive adenoids, a chronically ruptured eardrum, sleep apnoea, or tympanostomy tubes
• Children undergoing current pharmacological therapies to prevent recurrent respiratory infections.
• Any other medical condition or circumstance that, in the investigator's judgment, would compromise the safety of the participant or the integrity of the study.