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

Liaquat University of Medical & Health Sciences

Status: Completed

Conditions: Upper Respiratory Tract Infection

Treatments: Dietary Supplement: Probiotic Streptococcus salivarius K12; Other: No probiotic supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT05840926

LUMHS/REC/181

Details and patient eligibility

About

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.

Full 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.

Enrollment: 287 patients

Sex: All

Ages: 1 to 3 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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287 participants in 2 patient groups

Probiotic Streptococcus salivarius K12 Treatment Group

Experimental group

Description:

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

Treatment:

Dietary Supplement: Probiotic Streptococcus salivarius K12

Control Group

Active Comparator group

Description:

Children who did not receive any probiotic treatment

Treatment:

Other: No probiotic supplementation