Clinical trial NCT05840926: Probiotic S. Salivarius K12 for the Prevention of Upper Respiratory Tract Infection in Nursery-age Children
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
Overall status: COMPLETED
Phase: NA
Conditions: Upper Respiratory Tract Infection
Lead sponsor: Liaquat University of Medical & Health Sciences
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 287
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Incidence of any Gastrointestinal upset
timeFrame: 03 Months
measure: Bacterial or respiratory viral infection
timeFrame: 03 Months
measure: Use of antibiotics or antivirals
timeFrame: 03 Months
Secondary outcomes:
measure: Other pathologies
timeFrame: 03 Months
Other outcomes:
Locations:
city: Jāmshoro
country: Pakistan
facility: Liaquat University Hospital
Study officials:
References:
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.
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.
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.
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. 2024 Feb;16(1):93-98. doi: 10.1007/s12602-022-10010-0. Epub 2022 Dec 8.