Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06370208
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-04-13
Brief Title:
Prophylactic Effect of Probiotic Streptococcus Salivarius K12 Against Recurrent Streptococcus Pyogenes Pharyngotonsillitis Infection in Pediatrics
Sponsor:
Liaquat University of Medical Health Sciences
Organization:
Liaquat University of Medical Health Sciences
Study Overview
Official Title:
Study to Investigate the Prophylactic Effect of Probiotic Streptococcus Salivarius K12 Supplementation Against Recurrent Streptococcus Pyogenes GAS Bacterial Pharyngotonsillitis in Children A Randomized Double-blind Controlled Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Recurrent Streptococcus pyogenes pharyngotonsillitis infection in children presents a significant health concern characterized by frequent episodes of sore throat fever and swollen tonsils These recurrent infections can lead to missed school days discomfort and potential complications if left untreated Current treatment typically involves antibiotics to eradicate the bacterial infection However drawbacks exist with this approach including the risk of antibiotic resistance disruption of the gut microbiota and potential adverse effects such as gastrointestinal upset or allergic reactions Moreover antibiotics do not prevent future episodes and may contribute to recurrent infections by disrupting the balance of the throat microbiome Therefore there is a growing interest in alternative approaches such as probiotics which aim to support the bodys natural defenses and restore microbial balance in the throat and oral cavity
Detailed Description:
Recurrent Streptococcus pyogenes pharyngotonsillitis infection presents a persistent challenge in pediatric healthcare often necessitating frequent antibiotic treatments with associated risks of antimicrobial resistance and disruption of the microbiota Streptococcus salivarius K12 a commensal bacterium naturally inhabiting the human oral cavity exhibits antimicrobial properties against pathogenic streptococci including Streptococcus pyogenes Moreover S salivarius K12 produces bacteriocin-like inhibitory substances BLIS that competitively inhibit the growth of pathogenic bacteria potentially offering a prophylactic strategy to mitigate recurrent infections This clinical trial aims to elucidate the scientific rationale underlying the use of probiotic S salivarius K12 as a preventive measure against recurrent Streptococcus pyogenes pharyngotonsillitis in children aged 3-10 years shedding light on its efficacy and safety in this vulnerable population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None