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

Liaquat University of Medical & Health Sciences

Status: Not yet enrolling

Conditions: Streptococcus Pyogenes Pharyngotonsillitis

Treatments: Dietary Supplement: Probiotic Bactoblis® EVOL (Streptococcus salivarius eK12)

Study type: Interventional

Funder types: Other

Identifiers

NCT06370208

LUMHS/B12/Temp/13.04.2024

Details and patient eligibility

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 the EU, holds potential as a safe, alternative intervention to reduce the incidence and severity of GAS infections without the drawbacks of antibiotic therapy.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 3 to 10 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Probiotic supplement group

Experimental group

Description:

Participants in this group will receive probiotic Streptococcus salivarius eK12 (Bactoblis® EVOLcontaining ca. 1 billion CFU of Streptococcus salivarius eK12/capsule) as daily one capsule (to be slowly dissolved in the mouth before sleeping at night time) for 3-months. There will be a further 3-months follow-up period.

Treatment:

Dietary Supplement: Probiotic Bactoblis® EVOL (Streptococcus salivarius eK12)

Control group

No Intervention group

Description:

Participants in this group will not receive probiotic Streptococcus salivarius eK12 (Bactoblis® EVOL).