Prophylactic Effect of Probiotic Streptococcus Salivarius eK12 Against Recurrent Streptococcus Py… (NCT06370208) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Prophylactic Effect of Probiotic Streptococcus Salivarius eK12 Against Recurrent Streptococcus Pyogenes Pharyngotonsillitis Infection in Pediatrics
Pakistan82 participantsStarted 2025-12-01
Plain-language summary
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.
Who can participate
Age range
3 Years – 10 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, obst…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recurrence of Streptococcus pyogenes pharyngotonsillitis infection
Timeframe: 6-months
2
Probiotic safety and tolerability
Timeframe: 6-months
Trial details
NCT IDNCT06370208
SponsorLiaquat University of Medical & Health Sciences