Upper Respiratory Tract InfectionPUNKNCT05840926
Probiotic S. Salivarius K12 for the Prevention of Upper Respiratory Tract Infection in Nursery-age Children
A study testing Probiotic Streptococcus salivarius K12 and No probiotic supplementation in people with Upper Respiratory Tract Infection, run by Liaquat University of Medical & Health Sciences at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 1 year to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Respiratory Tract Infection
- What is being tested?
- Probiotic Streptococcus salivarius K12 and No probiotic supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 287 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Jan 2022to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Children with underlying health condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Possible Prophylactic Role of the S. Salivarius K12 Probiotic Strain for the Upper Respiratory Tract Infection and Nursery-age Children
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.
Read the 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.
- Conditions
- Upper Respiratory Tract Infection
- Being tested
- Probiotic Streptococcus salivarius K12, No probiotic supplementation
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic Streptococcus salivarius K12Dietary supplement
Oral 1 billion CFU of Probiotic Streptococcus salivarius K12
No probiotic supplementationOther
Children who did not receive any probiotic supplementation
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Streptococcus salivarius K12 Treatment Group | Experimental | Children treated with Probiotic Streptococcus salivarius K12 Treatment for continuous 3-months Receives: Dietary Supplement: Probiotic Streptococcus salivarius K12 |
| Control Group | Active comparator | Children who did not receive any probiotic treatment Receives: Other: No probiotic supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of any Gastrointestinal upset
Safety and tolerability of the probiotic treatment
Measured: 03 Months
Bacterial or respiratory viral infection
Evaluation of the frequency of bacterial or respiratory viral infection
Measured: 03 Months
Use of antibiotics or antivirals
Evaluation of the frequency of use of antibiotic or antiviral therapies
Measured: 03 Months
Secondary outcomes (1)
Other pathologies
Evaluation of the frequency of incidence of other pathologies such as GI
Measured: 03 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start5 Jan 2022
- Primary completion20 Dec 2022
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Upper Respiratory Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liaquat University of Medical & Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Amjad Khan, Liaquat University of Medical & Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05840926
- Sponsor's protocol ID
- LUMHS/REC/181
- Acronym
- PUNK
- Status last verified
- Apr 2023
- First submitted
- 1 Apr 2023
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29322750Sarlin 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.
PubMed 33298762Burton 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.
PubMed 21722694Laws 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.
PubMed 36477439
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Possible Prophylactic Role of the S. Salivarius K12 Probiotic Strain for the Upper Respiratory Tract Infection and Nursery-age Children
- ClinicalTrials.gov ID
- NCT05840926
- Acronym / sponsor ID
- PUNK / LUMHS/REC/181
- Conditions
- Upper Respiratory Tract Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- Liaquat University of Medical & Health SciencesUniversity, hospital or other
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic Streptococcus salivarius K12 Treatment Group | Experimental | Dietary Supplement: Probiotic Streptococcus salivarius K12Children treated with Probiotic Streptococcus salivarius K12 Treatment for continuous 3-months |
| Control Group | Active comparator | Other: No probiotic supplementationChildren who did not receive any probiotic treatment |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Children with underlying health condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic Streptococcus salivarius K12Oral 1 billion CFU of Probiotic Streptococcus salivarius K12 | Dietary supplement | Probiotic Streptococcus salivarius K12 Treatment Group |
| No probiotic supplementationChildren who did not receive any probiotic supplementation | Other | Control Group |
Primary outcome
Incidence of any Gastrointestinal upset
Time frame: 03 Months
Safety and tolerability of the probiotic treatment
Bacterial or respiratory viral infection
Time frame: 03 Months
Evaluation of the frequency of bacterial or respiratory viral infection
Use of antibiotics or antivirals
Time frame: 03 Months
Evaluation of the frequency of use of antibiotic or antiviral therapies
1 secondary outcome
Other pathologies
Time frame: 03 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Background: PubMed 29322750Di 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.
- Background: PubMed 33298762Sarlin 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.
- Background: PubMed 21722694Burton 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.
- Background: PubMed 36477439Laws 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic Streptococcus salivarius K12 and No probiotic supplementation in people with Upper Respiratory Tract Infection, run by Liaquat University of Medical & Health Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of any Gastrointestinal upset (time frame: 03 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05840926, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.