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

Possible Prophylactic Role of the S. Salivarius K12 Probiotic Strain for the Upper Respiratory Tract Infection and Nursery-age Children

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05840926

Acronym

PUNK

Enrollment

287

Registered

2023-05-03

Start date

2022-01-05

Completion date

2023-03-31

Last updated

2023-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Upper Respiratory Tract Infection

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.

Interventions

DIETARY_SUPPLEMENTProbiotic Streptococcus salivarius K12

Oral 1 billion CFU of Probiotic Streptococcus salivarius K12

OTHERNo probiotic supplementation

Children who did not receive any probiotic supplementation

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 3 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Other pathologies	03 Months	Evaluation of the frequency of incidence of other pathologies such as GI

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026