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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

287 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-05

Study Completion Date

2023-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT06370208

Streptococcus Pyogenes Pharyngotonsillitis

RECRUITING NA

Study to Investigate the Treatment Benefits of Probiotic Streptococcus Salivarius K12 for Hospitalised Patients (Non-ICU) With COVID-19

NCT05043376

Covid19

COMPLETED NA

Evaluation of Safety and Human Tolerance of Oral Probiotic Streptococcus Salivarius eK12

NCT06380270

Safety Tolerability

COMPLETED NA

Probiotics in Respiratory Tract Infections in Children

NCT01510938

Infections, Respiratory Tract

COMPLETED PHASE2

Evaluation of Probiotics on Symptoms of Upper Respiratory Tract Infections

NCT00599430

Healthy

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Upper Respiratory Tract Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Probiotic Streptococcus salivarius K12 Treatment Group

Children treated with Probiotic Streptococcus salivarius K12 Treatment for continuous 3-months

Group Type EXPERIMENTAL

Probiotic Streptococcus salivarius K12

Intervention Type DIETARY_SUPPLEMENT

Oral 1 billion CFU of Probiotic Streptococcus salivarius K12

Control Group

Children who did not receive any probiotic treatment

Group Type ACTIVE_COMPARATOR

No probiotic supplementation

Intervention Type OTHER

Children who did not receive any probiotic supplementation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Probiotic Streptococcus salivarius K12

Oral 1 billion CFU of Probiotic Streptococcus salivarius K12

Intervention Type DIETARY_SUPPLEMENT

No probiotic supplementation

Children who did not receive any probiotic supplementation

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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