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

• Sponsor: Liaquat University of Medical & Health Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT05840926
• Collaborator: (none)
• Enrollment: 287
• Location: 1
• Arms: 2
• Actual Duration (Months): 14.8
• Patients Per Site Per Month: 19.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Upper Respiratory Tract Infection	Dietary Supplement: Probiotic Streptococcus salivarius K12; Other: No probiotic supplementation	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 287 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Possible Prophylactic Role of the S. Salivarius K12 Probiotic Strain for the Upper Respiratory Tract Infection and Nursery-age Children
• Actual Study Start Date: Jan 5, 2022
• Actual Primary Completion Date: Dec 20, 2022
• Actual Study Completion Date: Mar 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Probiotic Streptococcus salivarius K12 Treatment Group Children treated with Probiotic Streptococcus salivarius K12 Treatment for continuous 3-months	Dietary Supplement: Probiotic Streptococcus salivarius K12; Oral 1 billion CFU of Probiotic Streptococcus salivarius K12
Active Comparator: Control Group Children who did not receive any probiotic treatment	Other: No probiotic supplementation; Children who did not receive any probiotic supplementation

Outcome Measures

Primary Outcome Measures

1. Incidence of any Gastrointestinal upset [03 Months]

   Safety and tolerability of the probiotic treatment

2. Bacterial or respiratory viral infection [03 Months]

   Evaluation of the frequency of bacterial or respiratory viral infection

3. Use of antibiotics or antivirals [03 Months]

   Evaluation of the frequency of use of antibiotic or antiviral therapies

Secondary Outcome Measures

1. Other pathologies [03 Months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 3 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Liaquat University Hospital	Jāmshoro		Pakistan

Sponsors and Collaborators

• Liaquat University of Medical & Health Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.

• Responsible Party: Dr. Amjad Khan, Professor, Liaquat University of Medical & Health Sciences
• ClinicalTrials.gov Identifier: NCT05840926
• Other Study ID Numbers: LUMHS/REC/181
• First Posted: May 3, 2023
• Last Update Posted: May 3, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections

Study Results

No Results Posted as of May 3, 2023