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

Upper Respiratory Tract Infection Clinical Trial

— PUNK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05840926
• Other study ID #: LUMHS/REC/181
• Status: Completed
• Phase: N/A
• Start date: January 5, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: April 2023
• Source: Liaquat University of Medical & Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 287
• Est. completion date: March 31, 2023
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 3 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Respiratory Tract Infections
• Upper Respiratory Tract Infection

Intervention

Dietary Supplement:
• Probiotic Streptococcus salivarius K12
Oral 1 billion CFU of Probiotic Streptococcus salivarius K12

Other:
• No probiotic supplementation
Children who did not receive any probiotic supplementation

Locations

Country	Name	City	State
Pakistan	Liaquat University Hospital	Jamshoro

Sponsors (1)

Lead Sponsor	Collaborator
Liaquat University of Medical & Health Sciences

Country where clinical trial is conducted

Pakistan, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of any Gastrointestinal upset	Safety and tolerability of the probiotic treatment	03 Months
Primary	Bacterial or respiratory viral infection	Evaluation of the frequency of bacterial or respiratory viral infection	03 Months
Primary	Use of antibiotics or antivirals	Evaluation of the frequency of use of antibiotic or antiviral therapies	03 Months
Secondary	Other pathologies	Evaluation of the frequency of incidence of other pathologies such as GI	03 Months