Lower Respiratory Tract InfectionNCT05374070
Antiviral Activity of Oral Probiotics
A study testing Streptococcus salivarius K12 Powder 1 Billion colony forming units /g), Streptococcus salivarius K12 Powder (1 Billion colony forming units /g) with a prebiotic included and Streptococcus salivarius M18 Powder (1 Billion colony forming units /g) in people with Lower Respiratory Tract Infection and Upper Respiratory Tract Infection, run by John Hale at 1 site in New Zealand.
Trial summary
The aim of this study is to test saliva samples obtained from healthy human participants for anti-viral activity after they have consumed S. salivarius probiotic in a powder format. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lower Respiratory Tract Infection, Upper Respiratory Tract Infection
- What is being tested?
- Streptococcus salivarius K12 Powder 1 Billion colony forming units /g), Streptococcus salivarius K12 Powder (1 Billion colony forming units /g) with a prebiotic included and Streptococcus salivarius M18 Powder (1 Billion colony forming units /g)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNew Zealand
- Study dates
- 23 May 2022to 15 Aug 2022
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In general good health 18 - 80 years of age.
- Practice good oral hygiene.
Who cannot join
- Have a history of autoimmune disease or are immunocompromised.
- Are on concurrent antibiotic therapy or regular antibiotic use within last 1 week
- History of allergy (e.g. dairy).
Trial locations and contacts
1 site in 1 country.
New Zealand1 site, 1 recruiting
- Recruiting
Blis Technologies Ltd
Dunedin, Otago, 9012
John D Hale, PhD, +6434740988, john.hale@blis.co.nz
Liam Harold, PhD, +6434740988, liam.harold@blis.co.nz
About this study
Official title: Assessment of Anti-viral Activity of Saliva Obtained From Human Volunteers Following Application of Probiotic Streptococcus Salivarius to the Oral Cavity
The aim of this study is to test saliva samples obtained from healthy human participants for anti-viral activity after they have consumed S. salivarius probiotic in a powder format.
Read the detailed description
This is a randomized controlled open pilot study to evaluate saliva samples collected from participants following their consumption of powders containing the commercially marketed probiotic bacterium S. salivarius K12 or S. salivarius M18.
Participants will be randomly assigned to one of the 4 groups consuming probiotic powder containing Streptococcus salivarius K12 or S. salivarius M18 with or without prebiotics (e.g. sugars that may promote probiotic activity). Saliva samples will be collected at predetermined time points pre and post intervention. Antibacterial and Antiviral activity will be determined following established assays. Colonisation efficacy will be determined by enumerating the probiotic in the saliva samples using standard microbiological techniques.
- Being tested
- Streptococcus salivarius K12 Powder 1 Billion colony forming units /g), Streptococcus salivarius K12 Powder (1 Billion colony forming units /g) with a prebiotic included, Streptococcus salivarius M18 Powder (1 Billion colony forming units /g), Streptococcus salivarius M18 Powder (1 Billion colony forming units /g) with a prebiotic included
- Keywords
- Streptococcus salivarius K12, Probiotic, Antiviral activity, Antibacterial activity, microbial colonization, oral probiotic, powder, prebiotic
- Medical subject headings
- Respiratory Tract Infections, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Streptococcus salivarius K12 Powder 1 Billion colony forming units /g)Dietary supplement
Probiotic Streptococcus salivarius K12 products are commercially available in traditional formats such as lozenges for local delivery in the oral cavity to provide oral health benefits. In this study, a powder formulation will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity.
Streptococcus salivarius K12 Powder (1 Billion colony forming units /g) with a prebiotic includedDietary supplement
In this study, a powder formulation containing Streptococcus salivarius K12 and a prebiotic will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity.
Streptococcus salivarius M18 Powder (1 Billion colony forming units /g)Dietary supplement
In this study, a powder formulation will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 to the oral cavity.
Streptococcus salivarius M18 Powder (1 Billion colony forming units /g) with a prebiotic includedDietary supplement
In this study, a powder formulation containing S. salivarius M18 and a prebiotic will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 to the oral cavity.
| Study group | Role | What they receive |
|---|---|---|
| Streptococcus salivarius K12 | Active comparator | Streptococcus salivarius K12 (Dose 1: 1 Billion colony forming units /g) Receives: Dietary Supplement: Streptococcus salivarius K12 Powder 1 Billion colony forming units /g) |
| Streptococcus salivarius K12 with a prebiotic included | Active comparator | Streptococcus salivarius K12 (Dose 1: 1 Billion colony forming units /g) Receives: Dietary Supplement: Streptococcus salivarius K12 Powder (1 Billion colony forming units /g) with a prebiotic included |
| Streptococcus salivarius M18 | Active comparator | Streptococcus salivarius M18 (Dose 1: 1 Billion colony forming units /g) Receives: Dietary Supplement: Streptococcus salivarius M18 Powder (1 Billion colony forming units /g) |
| Streptococcus salivarius M18 with a prebiotic included | Active comparator | Streptococcus salivarius M18 (Dose 1: 1 Billion colony forming units /g) Receives: Dietary Supplement: Streptococcus salivarius M18 Powder (1 Billion colony forming units /g) with a prebiotic included |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in antiviral activity following dosing with probiotic S. salivarius K12 in saliva from Day 0 (baseline) to 3 hours
Study will determine the antiviral activity of Streptococcus salivarius K12 without prebiotic in a powder format. The antiviral and antibacterial activity in the saliva will be determined using appropriate assays and Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data for different days (pre and post time points) and different formulations with the level of significance of p≤0.05.Overall colonization based on percentage of population colonized for different interventions will also be analyzed average and standard deviation functions using appropriate statistical analysis software (e.g Microsoft Excel).
Measured: 3 hours post intervention
Change in antiviral activity following dosing with probiotic S. salivarius K12 in saliva from Day 0 (baseline) to 8 hours
Study will determine the antiviral activity of Streptococcus salivarius K12 without prebiotic in a powder format. The antiviral and antibacterial activity in the saliva will be determined using appropriate assays and Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data for different days (pre and post time points) and different formulations with the level of significance of p≤0.05.Overall colonization based on percentage of population colonized for different interventions will also be analyzed average and standard deviation functions using appropriate statistical analysis software (e.g Microsoft Excel).
Measured: 8 hours post intervention
Change in antiviral activity following dosing with probiotic S. salivarius K12 with prebiotic in saliva from Day 0 (baseline) to 3 hours
Study will determine the antiviral activity of Streptococcus salivarius K12 with prebiotic in a powder format. The antiviral and antibacterial activity in the saliva will be determined using appropriate assays and Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data for different days (pre and post time points) and different formulations with the level of significance of p≤0.05.Overall colonization based on percentage of population colonized for different interventions will also be analyzed average and standard deviation functions using appropriate statistical analysis software (e.g Microsoft Excel).
Measured: 3 hours post intervention
Change in antiviral activity following dosing with probiotic S. salivarius K12 with prebiotic in saliva from Day 0 (baseline) to 8 hours
Study will determine the antiviral activity of Streptococcus salivarius K12 with prebiotic in a powder format. The antiviral and antibacterial activity in the saliva will be determined using appropriate assays and Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data for different days (pre and post time points) and different formulations with the level of significance of p≤0.05.Overall colonization based on percentage of population colonized for different interventions will also be analyzed average and standard deviation functions using appropriate statistical analysis software (e.g Microsoft Excel)
Measured: 8 hours post intervention
Change in antiviral activity following dosing with probiotic S. salivarius M18 in saliva from Day 0 (baseline) to 3 hours
Study will determine the antibacterial activity of Streptococcus salivarius M18 without prebiotic in a powder format. The antibacterial activity in the saliva will be determined using appropriate assays and Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data for different days (pre and post time points) and different formulations with the level of significance of p≤0.05.
Measured: 3 hours post intervention
Change in antiviral activity following dosing with probiotic S. salivarius M18 in saliva from Day 0 (baseline) to 8 hours
Study will determine the antibacterial activity of Streptococcus salivarius M18 without prebiotic in a powder format. The antibacterial activity in the saliva will be determined using appropriate assays and Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data for different days (pre and post time points) and different formulations with the level of significance of p≤0.05.
Measured: 8 hours post intervention
Change in antiviral activity following dosing with probiotic S. salivarius M18 with prebiotic in saliva from Day 0 (baseline) to 3 hours
Study will determine the antibacterial activity of Streptococcus salivarius M18 with prebiotic in a powder format. The antibacterial activity in the saliva will be determined using appropriate assays and Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data for different days (pre and post time points) and different formulations with the level of significance of p≤0.05.
Measured: 3 hours post intervention
Change in antiviral activity following dosing with probiotic S. salivarius M18 with prebiotic in saliva from Day 0 (baseline) to 8 hours
Study will determine the antibacterial activity of Streptococcus salivarius M18 with prebiotic in a powder format. The antibacterial activity in the saliva will be determined using appropriate assays and Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data for different days (pre and post time points) and different formulations with the level of significance of p≤0.05.
Measured: 8 hours post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start23 May 2022 (estimated)
- Primary completion23 Jun 2022 (estimated)
- Study completion15 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lower 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of the 4 groups consuming powder containing Streptococcus salivarius K12 or S. salivarius M18 with or without prebiotic: 1. Probiotic Streptococcus salivarius K12 Powder (Dose: 1 Billion cfu/g) 2. Probiotic Streptococcus salivarius K12 Powder with prebiotic (Dose: 1 Billion cfu/g) 3. Probiotic Streptococcus salivarius M18 Powder (Dose: 1 Billion cfu/g) 4. Probiotic Streptococcus salivarius M18 Powder with prebiotic (Dose: 1 Billion cfu/g)
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- John Hale
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, John Hale, BLIS Technologies Limited
- Investigators
- John D Hale, PhD, Study director, Blis Technologies Ltd, Dunedin, New ZealandJohn R Tagg, PhD, Principal investigator, Blis Technologies Ltd, Dunedin, New ZealandLiam Harold, PhD, Principal investigator, Blis Technologies Ltd, Dunedin, New Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05374070
- Sponsor's protocol ID
- BLTCT2022/2
- Status last verified
- May 2022
- First submitted
- 9 May 2022
- Last updated
- 13 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data information and information included in the protocol and the Clinical study report will be shared to other researchers and/or in publications in due course.
Publications
Hyink O, Wescombe PA, Upton M, Ragland N, Burton JP, Tagg JR. Salivaricin A2 and the novel lantibiotic salivaricin B are encoded at adjacent loci on a 190-kilobase transmissible megaplasmid in the oral probiotic strain Streptococcus salivarius K12. Appl Environ Microbiol. 2007 Feb;73(4):1107-13. doi: 10.1128/AEM.02265-06. Epub 2006 Dec 28.
PubMed 17194838Burton JP, Chilcott CN, Wescombe PA, Tagg JR. Extended Safety Data for the Oral Cavity Probiotic Streptococcus salivarius K12. Probiotics Antimicrob Proteins. 2010 Oct;2(3):135-44. doi: 10.1007/s12602-010-9045-4.
PubMed 26781236
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Anti-viral Activity of Saliva Obtained From Human Volunteers Following Application of Probiotic Streptococcus Salivarius to the Oral Cavity
- ClinicalTrials.gov ID
- NCT05374070
- Acronym / sponsor ID
- BLTCT2022/2
- Keywords
- Streptococcus salivarius K12, Probiotic, Antiviral activity, Antibacterial activity, microbial colonization, oral probiotic, powder, prebiotic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- John HaleIndustry (pharma, biotech, devices)
- Study start
- 23 May 2022 (estimated)
- Primary completion
- 23 Jun 2022 (estimated)
- Study completion
- 15 Aug 2022 (estimated)
- First posted
- 13 May 2022 (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 aim of this study is to test saliva samples obtained from healthy human participants for anti-viral activity after they have consumed S. salivarius probiotic in a powder format.
Detailed description
This is a randomized controlled open pilot study to evaluate saliva samples collected from participants following their consumption of powders containing the commercially marketed probiotic bacterium S. salivarius K12 or S. salivarius M18.
Participants will be randomly assigned to one of the 4 groups consuming probiotic powder containing Streptococcus salivarius K12 or S. salivarius M18 with or without prebiotics (e.g. sugars that may promote probiotic activity). Saliva samples will be collected at predetermined time points pre and post intervention. Antibacterial and Antiviral activity will be determined following established assays. Colonisation efficacy will be determined by enumerating the probiotic in the saliva samples using standard microbiological techniques.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants will be randomly assigned to one of the 4 groups consuming powder containing Streptococcus salivarius K12 or S. salivarius M18 with or without prebiotic: 1. Probiotic Streptococcus salivarius K12 Powder (Dose: 1 Billion cfu/g) 2. Probiotic Streptococcus salivarius K12 Powder with prebiotic (Dose: 1 Billion cfu/g) 3. Probiotic Streptococcus salivarius M18 Powder (Dose: 1 Billion cfu/g) 4. Probiotic Streptococcus salivarius M18 Powder with prebiotic (Dose: 1 Billion cfu/g)
| Arm | Type | Receives |
|---|---|---|
| Streptococcus salivarius K12 | Active comparator | Dietary Supplement: Streptococcus salivarius K12 Powder 1 Billion colony forming units /g)Streptococcus salivarius K12 (Dose 1: 1 Billion colony forming units /g) |
| Streptococcus salivarius K12 with a prebiotic included | Active comparator | Dietary Supplement: Streptococcus salivarius K12 Powder (1 Billion colony forming units /g) with a prebiotic includedStreptococcus salivarius K12 (Dose 1: 1 Billion colony forming units /g) |
| Streptococcus salivarius M18 | Active comparator | Dietary Supplement: Streptococcus salivarius M18 Powder (1 Billion colony forming units /g)Streptococcus salivarius M18 (Dose 1: 1 Billion colony forming units /g) |
| Streptococcus salivarius M18 with a prebiotic included | Active comparator | Dietary Supplement: Streptococcus salivarius M18 Powder (1 Billion colony forming units /g) with a prebiotic includedStreptococcus salivarius M18 (Dose 1: 1 Billion colony forming units /g) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- In general good health 18 - 80 years of age.
- Practice good oral hygiene.
Key exclusion criteria (3 listed)
- Have a history of autoimmune disease or are immunocompromised.
- Are on concurrent antibiotic therapy or regular antibiotic use within last 1 week
- History of allergy (e.g. dairy).
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 |
|---|---|---|
| Streptococcus salivarius K12 Powder 1 Billion colony forming units /g)Probiotic Streptococcus salivarius K12 products are commercially available in traditional formats such as lozenges for local delivery in the oral cavity to provide oral health benefits. In this study, a powder formulation will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity. | Dietary supplement | Streptococcus salivarius K12 |
| Streptococcus salivarius K12 Powder (1 Billion colony forming units /g) with a prebiotic includedIn this study, a powder formulation containing Streptococcus salivarius K12 and a prebiotic will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity. | Dietary supplement | Streptococcus salivarius K12 with a prebiotic included |
| Streptococcus salivarius M18 Powder (1 Billion colony forming units /g)In this study, a powder formulation will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 to the oral cavity. | Dietary supplement | Streptococcus salivarius M18 |
| Streptococcus salivarius M18 Powder (1 Billion colony forming units /g) with a prebiotic includedIn this study, a powder formulation containing S. salivarius M18 and a prebiotic will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 to the oral cavity. | Dietary supplement | Streptococcus salivarius M18 with a prebiotic included |
Primary outcome
Change in antiviral activity following dosing with probiotic S. salivarius K12 in saliva from Day 0 (baseline) to 3 hours
Time frame: 3 hours post intervention
Study will determine the antiviral activity of Streptococcus salivarius K12 without prebiotic in a powder format. The antiviral and antibacterial activity in the saliva will be determined using appropriate assays and Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data for different days (pre and post time points) and different formulations with the level of significance of p≤0.05.Overall colonization based on percentage of population colonized for different interventions will also be analyzed average and standard deviation functions using appropriate statistical analysis software (e.g Microsoft Excel).
Change in antiviral activity following dosing with probiotic S. salivarius K12 in saliva from Day 0 (baseline) to 8 hours
Time frame: 8 hours post intervention
Study will determine the antiviral activity of Streptococcus salivarius K12 without prebiotic in a powder format. The antiviral and antibacterial activity in the saliva will be determined using appropriate assays and Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data for different days (pre and post time points) and different formulations with the level of significance of p≤0.05.Overall colonization based on percentage of population colonized for different interventions will also be analyzed average and standard deviation functions using appropriate statistical analysis software (e.g Microsoft Excel).
Change in antiviral activity following dosing with probiotic S. salivarius K12 with prebiotic in saliva from Day 0 (baseline) to 3 hours
Time frame: 3 hours post intervention
Study will determine the antiviral activity of Streptococcus salivarius K12 with prebiotic in a powder format. The antiviral and antibacterial activity in the saliva will be determined using appropriate assays and Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data for different days (pre and post time points) and different formulations with the level of significance of p≤0.05.Overall colonization based on percentage of population colonized for different interventions will also be analyzed average and standard deviation functions using appropriate statistical analysis software (e.g Microsoft Excel).
Change in antiviral activity following dosing with probiotic S. salivarius K12 with prebiotic in saliva from Day 0 (baseline) to 8 hours
Time frame: 8 hours post intervention
Study will determine the antiviral activity of Streptococcus salivarius K12 with prebiotic in a powder format. The antiviral and antibacterial activity in the saliva will be determined using appropriate assays and Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data for different days (pre and post time points) and different formulations with the level of significance of p≤0.05.Overall colonization based on percentage of population colonized for different interventions will also be analyzed average and standard deviation functions using appropriate statistical analysis software (e.g Microsoft Excel)
Change in antiviral activity following dosing with probiotic S. salivarius M18 in saliva from Day 0 (baseline) to 3 hours
Time frame: 3 hours post intervention
Study will determine the antibacterial activity of Streptococcus salivarius M18 without prebiotic in a powder format. The antibacterial activity in the saliva will be determined using appropriate assays and Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data for different days (pre and post time points) and different formulations with the level of significance of p≤0.05.
Change in antiviral activity following dosing with probiotic S. salivarius M18 in saliva from Day 0 (baseline) to 8 hours
Time frame: 8 hours post intervention
Study will determine the antibacterial activity of Streptococcus salivarius M18 without prebiotic in a powder format. The antibacterial activity in the saliva will be determined using appropriate assays and Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data for different days (pre and post time points) and different formulations with the level of significance of p≤0.05.
Change in antiviral activity following dosing with probiotic S. salivarius M18 with prebiotic in saliva from Day 0 (baseline) to 3 hours
Time frame: 3 hours post intervention
Study will determine the antibacterial activity of Streptococcus salivarius M18 with prebiotic in a powder format. The antibacterial activity in the saliva will be determined using appropriate assays and Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data for different days (pre and post time points) and different formulations with the level of significance of p≤0.05.
Change in antiviral activity following dosing with probiotic S. salivarius M18 with prebiotic in saliva from Day 0 (baseline) to 8 hours
Time frame: 8 hours post intervention
Study will determine the antibacterial activity of Streptococcus salivarius M18 with prebiotic in a powder format. The antibacterial activity in the saliva will be determined using appropriate assays and Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data for different days (pre and post time points) and different formulations with the level of significance of p≤0.05.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
- Background: PubMed 17194838Hyink O, Wescombe PA, Upton M, Ragland N, Burton JP, Tagg JR. Salivaricin A2 and the novel lantibiotic salivaricin B are encoded at adjacent loci on a 190-kilobase transmissible megaplasmid in the oral probiotic strain Streptococcus salivarius K12. Appl Environ Microbiol. 2007 Feb;73(4):1107-13. doi: 10.1128/AEM.02265-06. Epub 2006 Dec 28.
- Background: PubMed 26781236Burton JP, Chilcott CN, Wescombe PA, Tagg JR. Extended Safety Data for the Oral Cavity Probiotic Streptococcus salivarius K12. Probiotics Antimicrob Proteins. 2010 Oct;2(3):135-44. doi: 10.1007/s12602-010-9045-4.
- Individual participant dataSharing planned: Yes. Data information and information included in the protocol and the Clinical study report will be shared to other researchers and/or in publications in due course.
Related trials for Lower Respiratory Tract Infection
RecruitingPhase 1
A Clinical Trial of V175 and V175A in Healthy Adults
Lower Respiratory Tract Infection
Not yet recruitingObservational study
Ultrasound Findings in a Pediatric Population
Respiratory Tract Infections (RTI), Lung Ultrasound
Recruiting
The Impact of MeMed BV® on Management of Patients With Suspected Lower Respiratory Tract Infections (LRTI) in the Emergency Department (ED) and Urgent Care Center (UCC) ("JUPITER" TRIAL)
Lower Respiratory Tract Infection
Not yet recruitingPhase 3
A Study to Evaluate Efficacy, Immunogenicity and Safety of a Recombinant Respiratory Syncytial Virus Vaccine in Older Adults Aged 60 Years and Older
Respiratory Syncytial Virus (RSV), Respiratory Syncytial Virus (RSV) Infection
Not yet recruiting
Multimodal Stewardship Programme to Improve Antibiotic Prescribing for Children With Lower Respiratory Tract Infections
Bronchitis, Acute, Community-acquired Pneumonia
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.
John D Hale, PhD study director
Blis Technologies Ltd, Dunedin, New Zealand
John R Tagg, PhD principal investigator
Blis Technologies Ltd, Dunedin, New Zealand
Liam Harold, PhD principal investigator
Blis Technologies Ltd, Dunedin, New Zealand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Streptococcus salivarius K12 Powder 1 Billion colony forming units /g), Streptococcus salivarius K12 Powder (1 Billion colony forming units /g) with a prebiotic included and Streptococcus salivarius M18 Powder (1 Billion colony forming units /g) in people with Lower Respiratory Tract Infection and Upper Respiratory Tract Infection, run by John Hale at 1 site in New Zealand.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 13 May 2022. 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 New Zealand. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John D Hale, PhD (6434740988, john.hale@blis.co.nz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in antiviral activity following dosing with probiotic S. salivarius K12 in saliva from Day 0 (baseline) to 3 hours (time frame: 3 hours post intervention). The study lists 8 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 NCT05374070, which also lists 2 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 13 May 2022.