Streptococcus Pyogenes Pharyngotonsillitis
Conditions
Brief 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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTProbiotic Bactoblis® EVOL (Streptococcus salivarius eK12)
Bactoblis® EVOL: containing one billion CFU of probiotic Streptococcus salivarius eK12
DIETARY_SUPPLEMENTOral vit D3
Oral vit D3 tablets (200 IU)
Sponsors
Liaquat University of Medical & Health Sciences
Università degli Studi dell'Insubria
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 11 Years
Healthy volunteers
Yes
Inclusion criteria
* Children aged 3-11 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of Streptococcus pyogenes pharyngotonsillitis infection | 6-months | Number of episodes of Streptococcus pyogenes pharyngotonsillitis infection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Group A Streptococcal (GAS) Symptoms | 6-months | Severity of GAS-associated symptoms assessed using a 10-point Visual Analogue Scale (VAS) |
| Protection against viral infection | 6-months | Number of incidences of viral throat infection |
| Protection against Acute Otitis Media infection | 6-months | Number of incidences of Acute Otitis Media infection |
| Protection against respiratory infection | 6-months | Number of incidences of Tracheitis infection |
| Protection against Rhinitis | 6-months | Number of incidences of Rhinitis |
| Protection against flu | 6-months | Number of incidences of flu |
| Protection against Enteritis | 6-months | Number of incidences of Enteritis infection |
| Protection against Stomatitis | 6-months | Number of incidences of Stomatitis infection |
| Use of Antibiotics | 6-months | Number of antibiotic courses prescribed during the 6-month study period. |
| Persistence of Streptococcus salivarius eK12 in saliva after washout | Month 6, approximately 3 months after discontinuation of eK12 supplementation. | 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. |
Countries
Pakistan
Outcome results
None listed