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Completed

NCT Number: NCT05840926

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

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.

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Key information

Age range

1 year–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Liaquat University Hospital

Jāmshoro, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic Streptococcus salivarius K12

Dietary Supplement

Oral 1 billion CFU of Probiotic Streptococcus salivarius K12

No probiotic supplementation

Other

Children who did not receive any probiotic supplementation

Primary outcomes

  1. Incidence of any Gastrointestinal upset

    Time frame: 03 Months

    Safety and tolerability of the probiotic treatment

  2. Bacterial or respiratory viral infection

    Time frame: 03 Months

    Evaluation of the frequency of bacterial or respiratory viral infection

  3. Use of antibiotics or antivirals

    Time frame: 03 Months

    Evaluation of the frequency of use of antibiotic or antiviral therapies

Secondary outcomes

  1. Other pathologies

    Time frame: 03 Months

    Evaluation of the frequency of incidence of other pathologies such as GI

Sponsors and collaborators

Lead sponsor

Liaquat University of Medical & Health Sciences

Other

Registry information

Official study title

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

Acronym: PUNK

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
May 3, 2023
Registry last updated
May 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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