NCT05840926

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
287

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 1, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 3, 2023

Completed
Last Updated

May 3, 2023

Status Verified

April 1, 2023

Enrollment Period

12 months

First QC Date

April 1, 2023

Last Update Submit

April 21, 2023

Conditions

Upper Respiratory Tract Infection

Outcome Measures

Primary Outcomes (3)

  • Incidence of any Gastrointestinal upset

    Safety and tolerability of the probiotic treatment

    03 Months

  • Bacterial or respiratory viral infection

    Evaluation of the frequency of bacterial or respiratory viral infection

    03 Months

  • Use of antibiotics or antivirals

    Evaluation of the frequency of use of antibiotic or antiviral therapies

    03 Months

Secondary Outcomes (1)

  • Other pathologies

    03 Months

Study Arms (2)

Probiotic Streptococcus salivarius K12 Treatment Group

EXPERIMENTAL

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

Dietary Supplement: Probiotic Streptococcus salivarius K12

Control Group

ACTIVE COMPARATOR

Children who did not receive any probiotic treatment

Other: No probiotic supplementation

Interventions

Probiotic Streptococcus salivarius K12DIETARY_SUPPLEMENT

Oral 1 billion CFU of Probiotic Streptococcus salivarius K12

Probiotic Streptococcus salivarius K12 Treatment Group
No probiotic supplementationOTHER

Children who did not receive any probiotic supplementation

Control Group

Eligibility Criteria

Age1 Year - 3 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Children with underlying health condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liaquat University Hospital

Jāmshoro, Pakistan

Location

Related Publications (4)

  • 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.

    PMID: 29322750BACKGROUND

  • 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.

    PMID: 33298762BACKGROUND

  • 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.

    PMID: 21722694BACKGROUND

  • 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. 2024 Feb;16(1):93-98. doi: 10.1007/s12602-022-10010-0. Epub 2022 Dec 8.

    PMID: 36477439BACKGROUND

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 1, 2023

First Posted

May 3, 2023

Study Start

January 5, 2022

Primary Completion

December 20, 2022

Study Completion

March 31, 2023

Last Updated

May 3, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)