Microbial ColonizationNCT05624177
Colonisation Efficacy of a Probiotic Chewing Gum.
A study testing Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum (chew 5 minutes) and Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum (chew 10 minutes) in people with Microbial Colonization, run by BLIS Technologies Limited at 1 site in New Zealand.
Trial summary
To evaluate the colonization efficacy (the ability of a probiotic bacteria to remain in the mouth) delivered in a chewing gum format. The chewing gum contains Streptococcus salivarius probiotic and the study is to be done in health adults. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Microbial Colonization
- What is being tested?
- Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum (chew 5 minutes) and Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum (chew 10 minutes)
- 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
- Dec 2022to 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In general, good health
- Practice good oral hygiene
Who cannot join
- Have a history of autoimmune disease or are immune compromised.
- Are on concurrent antibiotic therapy, or regular antibiotic use within last one week
- People with allergies or sensitivities to 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
About this study
To evaluate the colonization efficacy (the ability of a probiotic bacteria to remain in the mouth) delivered in a chewing gum format. The chewing gum contains Streptococcus salivarius probiotic and the study is to be done in health adults.
Read the detailed description
This is a single blind, randomized controlled study to evaluate the colonization effectiveness of a chewing gum containing a commercially available probiotic bacterium. Participants will be randomly assigned to one of the two groups consuming chewing gum containing Streptococcus salivarius M18 over a 7-day period. Saliva samples will be collected at pre determined points (pre and post intervention). Colonization efficacy will be determined by enumerating the probiotic from the saliva samples using standard microbiological techniques.
- Conditions
- Microbial Colonization
- Being tested
- Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum (chew 5 minutes), Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum (chew 10 minutes)
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum (chew 5 minutes)Dietary supplement
Probiotic Streptococcus salivarius M18 products are commercially available in traditional formats such as a chewable tablet (lozenge) for local delivery to the oral cavity to provide health benefits. In this study, a chewing gum formulation will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 to the oral cavity.
Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum (chew 10 minutes)Dietary supplement
Probiotic Streptococcus salivarius M18 products are commercially available in traditional formats such as a chewable tablet (lozenge) for local delivery to the oral cavity to provide health benefits. In this study, a chewing gum formulation will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 to the oral cavity.
| Study group | Role | What they receive |
|---|---|---|
| Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum: Chew 5 minutes | Active comparator | Streptococcus salivarius M18 chewing gum 1 billion cfu chewing the gum for 5 minutes duration. Receives: Dietary Supplement: Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum (chew 5 minutes) |
| Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum: Chew 10 minutes | Active comparator | Streptococcus salivarius M18 chewing gum 1 billion cfu chewing the gum for 10 minutes duration. Receives: Dietary Supplement: Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum (chew 10 minutes) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Microbial colonization from baseline (Day 0) to 1 hour.
Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 chewing gum after two different times of chewing (5 vs 10 minutes). The statistical analysis will be carried out to compare the participants saliva data from baseline to post 1 hour across two different times of chewing exposure with a level of significance of p<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software.
Measured: 1 hour post intervention.
Change in Microbial colonization from baseline (Day 0) to 8 hours.
Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 chewing gum after two different times of chewing (5 vs 10 minutes). The statistical analysis will be carried out to compare the participants saliva data from baseline to post 8 hours across two different times of chewing exposure with a level of significance of p<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software.
Measured: 8 hours post intervention.
Change in Microbial colonization from baseline (Day 0) to 8 hours post last dose.
Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 chewing gum after two different times of chewing (5 vs 10 minutes). The statistical analysis will be carried out to compare the participants saliva data from baseline to post 8 hours following twice daily administration of probiotic, across two different times of chewing exposure with a level of significance of p<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software.
Measured: 8 hours past last dose following 7 days of twice daily administration of probiotic.
Change in Microbial colonization from baseline (Day 0) to 48 hours post last dose.
Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 chewing gum after two different times of chewing (5 vs 10 minutes). The statistical analysis will be carried out to compare the participants saliva data from baseline to post 48 hours following twice daily administration of probiotic, across two different times of chewing exposure with a level of significance of p<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software.
Measured: 48 hours past last dose following 7 days of twice daily administration of probiotic.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2022
- Study startDec 2022 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Microbial ColonizationStudies 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 two groups consuming chewing gum containing Streptococcus salivarius M18. Group A: Probiotic Streptococcus salivarius M18 chewing gum (dose: 1 billion colony forming units per gum tablet) and chew for 5 minutes duration. Group B: Probiotic Streptococcus salivarius M18 chewing gum (dose: 1 billion colony forming units per gum tablet) and chew for 10-20 minutes
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BLIS Technologies Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05624177
- Sponsor's protocol ID
- BLTCT2022/7
- Status last verified
- Nov 2022
- First submitted
- 14 Nov 2022
- Last updated
- 23 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 26781236Bardellini E, Amadori F, Gobbi E, Ferri A, Conti G, Majorana A. Does Streptococcus Salivarius Strain M18 Assumption Make Black Stains Disappear in Children? Oral Health Prev Dent. 2020 Apr 3;18(2):161-164. doi: 10.3290/j.ohpd.a43359.
PubMed 32099975Burton JP, Drummond BK, Chilcott CN, Tagg JR, Thomson WM, Hale JDF, Wescombe PA. Influence of the probiotic Streptococcus salivarius strain M18 on indices of dental health in children: a randomized double-blind, placebo-controlled trial. J Med Microbiol. 2013 Jun;62(Pt 6):875-884. doi: 10.1099/jmm.0.056663-0. Epub 2013 Feb 28.
PubMed 23449874Gregori G, Righi O, Risso P, Boiardi G, Demuru G, Ferzetti A, Galli A, Ghisoni M, Lenzini S, Marenghi C, Mura C, Sacchetti R, Suzzani L. Reduction of group A beta-hemolytic streptococcus pharyngo-tonsillar infections associated with use of the oral probiotic Streptococcus salivarius K12: a retrospective observational study. Ther Clin Risk Manag. 2016 Jan 19;12:87-92. doi: 10.2147/TCRM.S96134. eCollection 2016.
PubMed 26855579Di Pierro F, Adami T, Rapacioli G, Giardini N, Streitberger C. Clinical evaluation of the oral probiotic Streptococcus salivarius K12 in the prevention of recurrent pharyngitis and/or tonsillitis caused by Streptococcus pyogenes in adults. Expert Opin Biol Ther. 2013 Mar;13(3):339-43. doi: 10.1517/14712598.2013.758711. Epub 2013 Jan 4.
PubMed 23286823Di Pierro F, Colombo M, Zanvit A, Rottoli AS. Positive clinical outcomes derived from using Streptococcus salivarius K12 to prevent streptococcal pharyngotonsillitis in children: a pilot investigation. Drug Healthc Patient Saf. 2016 Nov 21;8:77-81. doi: 10.2147/DHPS.S117214. eCollection 2016.
PubMed 27920580Di Pierro F, Colombo M, Giuliani MG, Danza ML, Basile I, Bollani T, Conti AM, Zanvit A, Rottoli AS. Effect of administration of Streptococcus salivarius K12 on the occurrence of streptococcal pharyngo-tonsillitis, scarlet fever and acute otitis media in 3 years old children. Eur Rev Med Pharmacol Sci. 2016 Nov;20(21):4601-4606.
PubMed 27874935Di Pierro F, Zanvit A, Nobili P, Risso P, Fornaini C. Cariogram outcome after 90 days of oral treatment with Streptococcus salivarius M18 in children at high risk for dental caries: results of a randomized, controlled study. Clin Cosmet Investig Dent. 2015 Oct 3;7:107-13. doi: 10.2147/CCIDE.S93066. eCollection 2015.
PubMed 26491371
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colonisation Efficacy of a Probiotic Chewing Gum.
- ClinicalTrials.gov ID
- NCT05624177
- Acronym / sponsor ID
- BLTCT2022/7
- Conditions
- Microbial Colonization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- BLIS Technologies LimitedIndustry (pharma, biotech, devices)
- Study start
- Dec 2022 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 22 Nov 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.
To evaluate the colonization efficacy (the ability of a probiotic bacteria to remain in the mouth) delivered in a chewing gum format. The chewing gum contains Streptococcus salivarius probiotic and the study is to be done in health adults.
Detailed description
This is a single blind, randomized controlled study to evaluate the colonization effectiveness of a chewing gum containing a commercially available probiotic bacterium. Participants will be randomly assigned to one of the two groups consuming chewing gum containing Streptococcus salivarius M18 over a 7-day period. Saliva samples will be collected at pre determined points (pre and post intervention). Colonization efficacy will be determined by enumerating the probiotic from the saliva samples using standard microbiological techniques.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two groups consuming chewing gum containing Streptococcus salivarius M18. Group A: Probiotic Streptococcus salivarius M18 chewing gum (dose: 1 billion colony forming units per gum tablet) and chew for 5 minutes duration. Group B: Probiotic Streptococcus salivarius M18 chewing gum (dose: 1 billion colony forming units per gum tablet) and chew for 10-20 minutes
| Arm | Type | Receives |
|---|---|---|
| Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum: Chew 5 minutes | Active comparator | Dietary Supplement: Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum (chew 5 minutes)Streptococcus salivarius M18 chewing gum 1 billion cfu chewing the gum for 5 minutes duration. |
| Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum: Chew 10 minutes | Active comparator | Dietary Supplement: Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum (chew 10 minutes)Streptococcus salivarius M18 chewing gum 1 billion cfu chewing the gum for 10 minutes duration. |
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
- Practice good oral hygiene
Key exclusion criteria (3 listed)
- Have a history of autoimmune disease or are immune compromised.
- Are on concurrent antibiotic therapy, or regular antibiotic use within last one week
- People with allergies or sensitivities to 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 M18 probiotic 1 billion colony forming units chewing gum (chew 5 minutes)Probiotic Streptococcus salivarius M18 products are commercially available in traditional formats such as a chewable tablet (lozenge) for local delivery to the oral cavity to provide health benefits. In this study, a chewing gum formulation will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 to the oral cavity. | Dietary supplement | Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum: Chew 5 minutes |
| Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum (chew 10 minutes)Probiotic Streptococcus salivarius M18 products are commercially available in traditional formats such as a chewable tablet (lozenge) for local delivery to the oral cavity to provide health benefits. In this study, a chewing gum formulation will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 to the oral cavity. | Dietary supplement | Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum: Chew 10 minutes |
Primary outcome
Change in Microbial colonization from baseline (Day 0) to 1 hour.
Time frame: 1 hour post intervention.
Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 chewing gum after two different times of chewing (5 vs 10 minutes). The statistical analysis will be carried out to compare the participants saliva data from baseline to post 1 hour across two different times of chewing exposure with a level of significance of p<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software.
Change in Microbial colonization from baseline (Day 0) to 8 hours.
Time frame: 8 hours post intervention.
Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 chewing gum after two different times of chewing (5 vs 10 minutes). The statistical analysis will be carried out to compare the participants saliva data from baseline to post 8 hours across two different times of chewing exposure with a level of significance of p<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software.
Change in Microbial colonization from baseline (Day 0) to 8 hours post last dose.
Time frame: 8 hours past last dose following 7 days of twice daily administration of probiotic.
Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 chewing gum after two different times of chewing (5 vs 10 minutes). The statistical analysis will be carried out to compare the participants saliva data from baseline to post 8 hours following twice daily administration of probiotic, across two different times of chewing exposure with a level of significance of p<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software.
Change in Microbial colonization from baseline (Day 0) to 48 hours post last dose.
Time frame: 48 hours past last dose following 7 days of twice daily administration of probiotic.
Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 chewing gum after two different times of chewing (5 vs 10 minutes). The statistical analysis will be carried out to compare the participants saliva data from baseline to post 48 hours following twice daily administration of probiotic, across two different times of chewing exposure with a level of significance of p<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 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.
- Background: PubMed 32099975Bardellini E, Amadori F, Gobbi E, Ferri A, Conti G, Majorana A. Does Streptococcus Salivarius Strain M18 Assumption Make Black Stains Disappear in Children? Oral Health Prev Dent. 2020 Apr 3;18(2):161-164. doi: 10.3290/j.ohpd.a43359.
- Background: PubMed 23449874Burton JP, Drummond BK, Chilcott CN, Tagg JR, Thomson WM, Hale JDF, Wescombe PA. Influence of the probiotic Streptococcus salivarius strain M18 on indices of dental health in children: a randomized double-blind, placebo-controlled trial. J Med Microbiol. 2013 Jun;62(Pt 6):875-884. doi: 10.1099/jmm.0.056663-0. Epub 2013 Feb 28.
- Background: PubMed 26855579Gregori G, Righi O, Risso P, Boiardi G, Demuru G, Ferzetti A, Galli A, Ghisoni M, Lenzini S, Marenghi C, Mura C, Sacchetti R, Suzzani L. Reduction of group A beta-hemolytic streptococcus pharyngo-tonsillar infections associated with use of the oral probiotic Streptococcus salivarius K12: a retrospective observational study. Ther Clin Risk Manag. 2016 Jan 19;12:87-92. doi: 10.2147/TCRM.S96134. eCollection 2016.
- Background: PubMed 23286823Di Pierro F, Adami T, Rapacioli G, Giardini N, Streitberger C. Clinical evaluation of the oral probiotic Streptococcus salivarius K12 in the prevention of recurrent pharyngitis and/or tonsillitis caused by Streptococcus pyogenes in adults. Expert Opin Biol Ther. 2013 Mar;13(3):339-43. doi: 10.1517/14712598.2013.758711. Epub 2013 Jan 4.
- Background: PubMed 27920580Di Pierro F, Colombo M, Zanvit A, Rottoli AS. Positive clinical outcomes derived from using Streptococcus salivarius K12 to prevent streptococcal pharyngotonsillitis in children: a pilot investigation. Drug Healthc Patient Saf. 2016 Nov 21;8:77-81. doi: 10.2147/DHPS.S117214. eCollection 2016.
- Background: PubMed 27874935Di Pierro F, Colombo M, Giuliani MG, Danza ML, Basile I, Bollani T, Conti AM, Zanvit A, Rottoli AS. Effect of administration of Streptococcus salivarius K12 on the occurrence of streptococcal pharyngo-tonsillitis, scarlet fever and acute otitis media in 3 years old children. Eur Rev Med Pharmacol Sci. 2016 Nov;20(21):4601-4606.
- Background: PubMed 26491371Di Pierro F, Zanvit A, Nobili P, Risso P, Fornaini C. Cariogram outcome after 90 days of oral treatment with Streptococcus salivarius M18 in children at high risk for dental caries: results of a randomized, controlled study. Clin Cosmet Investig Dent. 2015 Oct 3;7:107-13. doi: 10.2147/CCIDE.S93066. eCollection 2015.
- 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.
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 M18 probiotic 1 billion colony forming units chewing gum (chew 5 minutes) and Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum (chew 10 minutes) in people with Microbial Colonization, run by BLIS Technologies Limited 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 23 Nov 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 (+64211735540, 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 Microbial colonization from baseline (Day 0) to 1 hour. (time frame: 1 hour post intervention.). The study lists 4 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 NCT05624177, which also lists 9 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 23 Nov 2022.