Probiotic S. Salivarius K12 for the Prevention of Upper Respiratory Tract Infection in Nursery-age Children

Not Applicable

Completed

• Conditions: Upper Respiratory Tract Infection
• Interventions: Dietary Supplement: Probiotic Streptococcus salivarius K12; Other: No probiotic supplementation

• Registration Number: NCT05840926
• Lead Sponsor: Liaquat University of Medical & Health Sciences

Brief Summary

The purpose of this retrospective study is to assess the treatment benefits of probiotic Streptococcus salivarius K12 for the prevention of recurrent bacterial and viral infections of the pharynx, tonsils and ears in children under 3 years of age.

Detailed Description

Recurrent bacterial and viral infections of the pharynx, tonsils and ears are a problem that can affect children of all ages. The persistence of these infections can lead to an overuse of drugs such as antibiotics, antipyretics and anti-inflammatories, with the possible consequent presence of side effects and above all an increase in antibiotic resistance, a global public health issue.

In search at reducing the use of antibiotics and antivirals, there is currently a great scientific interest in probiotic therapies for the oral cavity infection.

The aim of this retrospective, controlled, multicenter, non-profit study is to evaluate the efficacy and safety of the administration of Streptococcus salivarius K12 in pediatric patients attending the 1st or 2nd year of nursery school (\< 3 years of age ), in the prophylaxis of the most common bacterial or viral respiratory infections, assessing the consequent reduction in the use of antibiotics, antivirals or other therapies compared to children.

Study Timeline

• Study Start: 2022-01-05
• Primary Completion: 2022-12-20
• Study Completion: 2023-03-31
• Status Verified: 2023-04
• Study First Submitted: 2023-04-01
• Study First Submitted QC: 2023-04-21
• Last Update Submitted: 2023-04-21
• Study First Posted: 2023-05-03
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 287

Inclusion Criteria

• Healthy children attending the 1st or 2nd year of nursery (under aged 3 years)
• Treated with probiotic Streptococcus salivarius K12 (1 billion CFU) for 90 continuous days
• Children not treated with probiotic Streptococcus salivarius K12

Exclusion Criteria

• Children with underlying health condition

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic Streptococcus salivarius K12 Treatment Group	Probiotic Streptococcus salivarius K12	Children treated with Probiotic Streptococcus salivarius K12 Treatment for continuous 3-months
Control Group	No probiotic supplementation	Children who did not receive any probiotic treatment

Primary Outcome Measures

Name	Time	Method
Incidence of any Gastrointestinal upset	03 Months	Safety and tolerability of the probiotic treatment
Bacterial or respiratory viral infection	03 Months	Evaluation of the frequency of bacterial or respiratory viral infection
Use of antibiotics or antivirals	03 Months	Evaluation of the frequency of use of antibiotic or antiviral therapies

Secondary Outcome Measures

Name	Time	Method
Other pathologies	03 Months	Evaluation of the frequency of incidence of other pathologies such as GI

Trial Locations

Locations (1)

Liaquat University Hospital; 🇵🇰 Jāmshoro, Pakistan