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

Primary Purpose

Upper Respiratory Tract Infection

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Probiotic Streptococcus salivarius K12
No probiotic supplementation
Sponsored by
Liaquat University of Medical & Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Upper Respiratory Tract Infection

Eligibility Criteria

1 Year - 3 Years (Child)All SexesAccepts 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

Sites / Locations

  • Liaquat University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Probiotic Streptococcus salivarius K12 Treatment Group

Control Group

Arm Description

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

Children who did not receive any probiotic treatment

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 1, 2023
Last Updated
April 21, 2023
Sponsor
Liaquat University of Medical & Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05840926
Brief Title
Probiotic S. Salivarius K12 for the Prevention of Upper Respiratory Tract Infection in Nursery-age Children
Acronym
PUNK
Official Title
Possible Prophylactic Role of the S. Salivarius K12 Probiotic Strain for the Upper Respiratory Tract Infection and Nursery-age Children
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 5, 2022 (Actual)
Primary Completion Date
December 20, 2022 (Actual)
Study Completion Date
March 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Liaquat University of Medical & Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Respiratory Tract Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
287 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probiotic Streptococcus salivarius K12 Treatment Group
Arm Type
Experimental
Arm Description
Children treated with Probiotic Streptococcus salivarius K12 Treatment for continuous 3-months
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Children who did not receive any probiotic treatment
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic Streptococcus salivarius K12
Intervention Description
Oral 1 billion CFU of Probiotic Streptococcus salivarius K12
Intervention Type
Other
Intervention Name(s)
No probiotic supplementation
Intervention Description
Children who did not receive any probiotic supplementation
Primary Outcome Measure Information:
Title
Incidence of any Gastrointestinal upset
Description
Safety and tolerability of the probiotic treatment
Time Frame
03 Months
Title
Bacterial or respiratory viral infection
Description
Evaluation of the frequency of bacterial or respiratory viral infection
Time Frame
03 Months
Title
Use of antibiotics or antivirals
Description
Evaluation of the frequency of use of antibiotic or antiviral therapies
Time Frame
03 Months
Secondary Outcome Measure Information:
Title
Other pathologies
Description
Evaluation of the frequency of incidence of other pathologies such as GI
Time Frame
03 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Liaquat University Hospital
City
Jāmshoro
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29322750
Citation
Di Pierro F, Risso P, Poggi E, Timitilli A, Bolloli S, Bruno M, Caneva E, Campus R, Giannattasio A. Use of Streptococcus salivarius K12 to reduce the incidence of pharyngo-tonsillitis and acute otitis media in children: a retrospective analysis in not-recurrent pediatric subjects. Minerva Pediatr. 2018 Jun;70(3):240-245. doi: 10.23736/S0026-4946.18.05182-4. Epub 2018 Jan 11.
Results Reference
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PubMed Identifier
33298762
Citation
Sarlin S, Tejesvi MV, Turunen J, Vanni P, Pokka T, Renko M, Tapiainen T. Impact of Streptococcus salivarius K12 on Nasopharyngeal and Saliva Microbiome: A Randomized Controlled Trial. Pediatr Infect Dis J. 2021 May 1;40(5):394-402. doi: 10.1097/INF.0000000000003016.
Results Reference
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PubMed Identifier
21722694
Citation
Burton JP, Cowley S, Simon RR, McKinney J, Wescombe PA, Tagg JR. Evaluation of safety and human tolerance of the oral probiotic Streptococcus salivarius K12: a randomized, placebo-controlled, double-blind study. Food Chem Toxicol. 2011 Sep;49(9):2356-64. doi: 10.1016/j.fct.2011.06.038. Epub 2011 Jun 21.
Results Reference
background
PubMed Identifier
36477439
Citation
Laws GA, Harold LK, Tagg JR, Hale JDF. Interferon Gamma Response in Human Saliva Following Exposure to the Oral Probiotic Streptococcus salivarius BLIS K12. Probiotics Antimicrob Proteins. 2022 Dec 8. doi: 10.1007/s12602-022-10010-0. Online ahead of print.
Results Reference
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Probiotic S. Salivarius K12 for the Prevention of Upper Respiratory Tract Infection in Nursery-age Children

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