Actively Recruiting
Prophylactic Effect of Probiotic Streptococcus Salivarius eK12 Against Recurrent Streptococcus Pyogenes Pharyngotonsillitis Infection in Pediatrics
Led by Liaquat University of Medical & Health Sciences · Updated on 2026-01-06
60
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
Sponsors
L
Liaquat University of Medical & Health Sciences
Lead Sponsor
U
Università degli Studi dell'Insubria
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prophylactic Effect of Probiotic Streptococcus Salivarius eK12 Against Recurrent Streptococcus Pyogenes Pharyngotonsillitis Infection in Pediatrics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 3-10 years
- Recent history of documented recurrent Streptococcus pyogenes pharyngotonsillitis infection in the last 6 months, or 4 or more episodes in the last 12 months
- Confirmation of S. pyogenes infection by McIsaac score 2 plus rapid throat swab or McIsaac score of 5
- Willingness to comply with study protocol and attend follow-up visits
- Written informed consent from parent or legal guardian
You will not qualify if you...
- Known allergies or hypersensitivity to probiotics or study product components
- Current use of antibiotics or use within the past 30 days
- Use of oral colonizing probiotics in the last 6 months
- Severe underlying medical conditions affecting immune system or gastrointestinal tract
- Participation in other clinical trials with investigational drugs or interventions
- Inability to comply with study requirements due to social or logistical reasons
- History of rheumatic disorders, bronchospasm, severe asthma, or allergy requiring corticosteroids
- Past tonsillectomy or indication for adeno-tonsillectomy; severe respiratory or systemic disorders
- Immunocompromised status or conditions favoring recurrent acute otitis media
- Current pharmacological therapies preventing recurrent respiratory infections
- Any medical condition that may compromise safety or study integrity as judged by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Liaquat University of Medical and Health Sciences
Jamshoro, Pakistan, 76090
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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