Microbial ColonizationNCT04784845
Lactamica 9: Neisseria Lactamica Inoculation in Late Pregnancy
A study testing N. lactamica Y92-1009 in people with Microbial Colonization, run by University of Southampton at 1 site in United Kingdom.
Trial summary
Bacteria living in the nose and throat are generally harmless, but in some circumstances cause infections of the lungs (pneumonia) and brain (meningitis), which are among the commonest causes of death worldwide in young children (especially newborns). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Microbial Colonization
- What is being tested?
- N. lactamica Y92-1009
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2021to 12 Jul 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All the following inclusion criteria must apply in order for the volunteer to be eligible for the study:
- Healthy adult aged 18 years or over on the day of enrolment.
- Singleton pregnancy, 34+0 to 36+6 weeks gestation on the day of enrolment.
- Documentation of a 20-week ultrasound scan with no life-limiting congenital anomalies, and no maxillofacial / otorhinolaryngological / neuroanatomical anomalies.
- Able and willing (in the Investigator's opinion) to comply with all study requirements.
- Able and willing to give written informed consent to participate in the study.
- Booked to receive antenatal care at University Hospital Southampton NHS Foundation Trust.
Who cannot join
- The volunteer may not enter the study if any of the following exclusion criteria apply:
- Any confirmed or suspected immunosuppressive or immunocompromised state, including: HIV infection; asplenia; recurrent severe infections; or use of immunosuppressant medication (for more than 14 days within the past 6 months, excluding topical and inhaled steroids).
- Planned use of immunosuppressant medication in later pregnancy or post-partum.
- Occupational, household or intimate contact with any immunosuppressed persons.
- Participation within the last 12 weeks in a clinical trial involving receipt of an investigational product, or planned use of an investigational product during the study period.
- Prior participation at any time in research studies involving inoculation with N. lactamica.
Show all 12Show fewer
- Use of oral or intravenous antibiotics within 30 days prior to the N. lactamica inoculation visit.
- Planned use of oral or intravenous antibiotics at any time during the study period (e.g. for planned elective caesarean section or group B streptococcus colonisation).
- Allergy to soya or yeast.
- Previous stillbirth or neonatal death.
- Pre-pregnancy diabetes mellitus.
- Any other finding that may (in the Investigator's opinion): increase the risk to the volunteer (or their fetus/infant or close contacts) of participating in the study; affect the volunteer's ability to participate in the study and complete follow-up; or impair interpretation of study data.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospital Southampton NHS Foundation Trust
Southampton, SO166YD
About this study
Official title: Lactamica 9: Defining Upper Respiratory Colonisation and Microbiome Evolution in Mother-infant Pairs Following Neisseria Lactamica Inoculation in Late Pregnancy
Bacteria living in the nose and throat are generally harmless, but in some circumstances cause infections of the lungs (pneumonia) and brain (meningitis), which are among the commonest causes of death worldwide in young children (especially newborns). Babies with certain 'good' bacteria in the nose and throat are less likely to have infections by such 'bad' bacteria. Scientists have tried giving probiotics ('good' bacteria swallowed or sprayed into the nose) to pregnant women, new mothers and babies. These studies show that many probiotics are safe, but the amount of bacteria given is often unknown, and it is unclear if they work. A more precise option is to use controlled inoculation, by inserting a specific amount of particular 'good' bacteria into the nose under carefully controlled conditions. Our team have previously shown that inoculation with Neisseria lactamica ('good' bacteria) safely and reliably decreases Neisseria meningitidis ('bad' bacteria) in healthy adults' noses. N. lactamica is a type of harmless bacteria found in over 40% of children aged 1-2 years, but is uncommon in newborns and adults.
We plan to inoculate 20 healthy pregnant women with N. lactamica nose drops, to find out if it is transferred to their babies after birth. Newborns become rapidly covered (colonised) with bacteria from their mothers, other people, and the environment, so this method mimics a natural way that babies receive bacteria. We will take saliva and nose swabs one day, one week, one month and four months after birth, and will use microbiological and genetic methods to study how the bacteria changes in babies compared with their mothers.
Read the detailed description
We plan to perform nasal inoculation with N. lactamica (wild type strain Y92-1009) in healthy pregnant women, to establish whether horizontal N. lactamica transfer to their neonates occurs, and to characterise the impact on the developing neonatal upper respiratory tract (URT) microbiome. If successful, this study will provide a novel model for inducing and capturing a natural colonisation event in neonates. Unlike traditional controlled human infection models, which capture inoculation-induced colonisation, this first-in-man model would study person-to-person commensal transmission, allowing comparison of microbiome changes and adaptive commensal microevolution in mother-infant pairs. We have already conducted relevant Patient and Public Involvement research, in which all 12 pregnant women interviewed reported approval for this proposed study, and 11 expressed that they would have been interested in taking part in such a study.
We will approach healthy pregnant women in their second and third trimesters of pregnancy. Eligibility screening and enrolment will take place at 34+0 to 36+6 weeks gestation, and 20 women (not already colonised with N. lactamica) will be inoculated nasally with 10^5 colony forming units N. lactamica Y92-1009 at 36+0 to 37+6 weeks gestation. Samples will be obtained from new mothers (nasopharyngeal, oropharyngeal and saliva) and their neonates (nasopharyngeal and saliva) at 1 day, 1 week, 1 month and 4 months post-partum. If possible, and with the volunteer's consent, we will collect an umbilical cord blood sample at delivery and an infant venous blood sample at 1 month and 4 months post-partum, for storage and use in future studies. We will also collect a maternal venous blood sample at 4 months post-partum, as well as a saliva swab from any household contacts aged under 5 years. Any natural N. lactamica carriers identified at screening will not be inoculated, but will be followed-up with their neonates for biological sampling.
Pharyngeal and saliva swabs will be suspended in storage medium, aliquoted and stored at -80°C. N. lactamica colonisation will be confirmed using selective agar, Gram stain, microscopy, and analytical profile index testing (and matrix-assisted laser desorption/ionization time-of-flight for inconclusive results). N. lactamica colonisation density will be quantified, isolates will be stored at -80°C, and Y92-1009 strain identity will be confirmed using targeted polymerase chain reaction (PCR).
Microbiome analysis will be performed on thawed aliquots of paired mother-neonate samples, by DNA extraction, 16S ribosomal ribonucleic acid (rRNA) gene PCR, and amplicon sequencing. Poor quality and chimeric sequence reads will be removed, and high quality reads will be trimmed, aligned and clustered for taxonomic classification and statistical analysis.
Paired maternal and neonatal isolates confirmed as N. lactamica Y92-1009 will be sequenced, and resulting genomes will be mapped to a complete N. lactamica Y92-1009 closed reference genome, to assess for evidence of distinct microevolution.
We will also compare paired microbiome profiles to identify candidate organisms that are present in mothers and their infants. Paired mother-neonate sample aliquots will be thawed and plated onto selective media, and isolates of candidate species will be identified using Gram stain, microscopy, and other relevant microbiological tests. Resulting isolates will be sequenced and analysed for evidence of strain sharing between mothers and their neonates, suggesting horizontal transfer.
- Conditions
- Microbial Colonization
- Being tested
- N. lactamica Y92-1009
- Keywords
- Human challenge study, Controlled human infection, Neonatal microbiome, Pregnancy, Respiratory Tract Infections, Meningitis, Respiratory microbiome
- Medical subject headings
- Communicable Diseases, Respiratory Tract Infections, Meningitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N. lactamica Y92-1009Biological
Lyophilised N. lactamica reconstituted in phosphate-buffered saline
| Study group | Role | What they receive |
|---|---|---|
| N. lactamica Y92-1009 | Experimental | Nasal inoculation with 10^5 CFU N. lactamica in 1ml phosphate-buffered saline via pipette to both nostrils; single inoculation at 36+0 to 37+6 weeks gestation Receives: Biological: N. lactamica Y92-1009 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal N. lactamica colonisation
Confirmation of neonatal (aged 0-30 days) N. lactamica colonisation by selective culture of biological (nasopharyngeal and/or saliva) samples
Measured: Up to 4 weeks post-partum
Secondary outcomes (5)
Adverse reactions or serious adverse events
Percentage of participants (women and their neonates) with adverse reactions or serious adverse events within the study period
Measured: Enrolment (34+0 to 36+6 weeks gestation) to 4 weeks post-partum
Neonatal N. lactamica Y92-1009 colonisation
Confirmation of N. lactamica Y92-1009 strain identity by targeted polymerase chain reaction in neonates found to be colonised with N. lactamica
Measured: Birth (0-24 hours post-partum), 7+/-3 days post-partum, 28+/-3 days post-partum
N. lactamica colonisation kinetics
Characterisation of N. lactamica colonisation density in inoculated volunteers versus their infants across study time points and sample types
Measured: Birth (0-24 hours post-partum), 7+/-3 days post-partum, 28+/-3 days post-partum
Upper respiratory microbiome
Characterisation of microbiome composition, alpha diversity (within one biological sample) and beta diversity (between different biological samples) in inoculated volunteers compared with their infants across study time points and sample types; and (if horizontal N. lactamica transfer is detected in at least some but not all infants) in infants colonised with N. lactamica compared with uncolonised infants.
Measured: Birth (0-24 hours post-partum), 7+/-3 days post-partum, 28+/-3 days post-partum
N. lactamica Y92-1009 microevolution
If horizontal N. lactamica transfer is detected in at least some infants: N. lactamica genome sequence for isolates derived from inoculated volunteers compared with their infants across study time points and sample types, and comparison with an N. lactamica Y92-1009 closed reference genome
Measured: Birth (0-24 hours post-partum), 7+/-3 days post-partum, 28+/-3 days post-partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start1 Oct 2021
- Primary completion12 Jul 2022
- Study completion12 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Not applicable
- Intervention model
- Single group
- Model description
- A single intervention cohort will receive one open label intervention (nasal inoculation with 10\^5 CFU N. lactamica). If any naturally-occurring N. lactamica carriers are identified at screening, they will not attend for inoculation with N. lactamica, but will be invited to remain in the study. They (and their neonates) will undergo the same follow-up visits and sampling as inoculated volunteers. This observational cohort is not considered a separate study arm, and there is no recruitment target for this cohort.
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Collaborators
- University of Edinburgh, University Hospital Southampton NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Christine E Jones, Principal investigator, University of SouthamptonRobert C Read, Principal investigator, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04784845
- Sponsor's protocol ID
- 61640
- Status last verified
- Aug 2022
- First submitted
- 3 Mar 2021
- Last updated
- 6 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Theodosiou AA, Bogaert D, Cleary DW, Dale AP, Gbesemete DF, Guy JM, Laver JR, Raud L, Jones CE, Read RC. Controlled human infection model of Neisseria lactamica in late pregnancy investigating mother-to-infant transmission in the UK: a single-arm pilot trial. Lancet Microbe. 2025 Apr;6(4):100986. doi: 10.1016/j.lanmic.2024.100986. Epub 2025 Feb 19.
PubMed 39986292Bevan JHJ, Theodosiou AA, Corner J, Dorey RB, Read RC, Jones CE. A Questionnaire-based Study Exploring Participant Perspectives in a Perinatal Human Challenge Trial. Pediatr Infect Dis J. 2023 Nov 1;42(11):935-941. doi: 10.1097/INF.0000000000004036. Epub 2023 Jul 18.
PubMed 37463362Theodosiou AA, Laver JR, Dale AP, Cleary DW, Jones CE, Read RC. Controlled human infection with Neisseria lactamica in late pregnancy to measure horizontal transmission and microbiome changes in mother-neonate pairs: a single-arm interventional pilot study protocol. BMJ Open. 2022 May 18;12(5):e056081. doi: 10.1136/bmjopen-2021-056081.
PubMed 35584870
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactamica 9: Defining Upper Respiratory Colonisation and Microbiome Evolution in Mother-infant Pairs Following Neisseria Lactamica Inoculation in Late Pregnancy
- ClinicalTrials.gov ID
- NCT04784845
- Acronym / sponsor ID
- 61640
- Conditions
- Microbial Colonization
- Keywords
- Human challenge study, Controlled human infection, Neonatal microbiome, Pregnancy, Respiratory Tract Infections, Meningitis, Respiratory microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Collaborators
- University of Edinburgh, University Hospital Southampton NHS Foundation Trust
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 12 Jul 2022 (actual)
- Study completion
- 12 Jul 2022 (actual)
- First posted
- 5 Mar 2021 (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.
Bacteria living in the nose and throat are generally harmless, but in some circumstances cause infections of the lungs (pneumonia) and brain (meningitis), which are among the commonest causes of death worldwide in young children (especially newborns). Babies with certain 'good' bacteria in the nose and throat are less likely to have infections by such 'bad' bacteria. Scientists have tried giving probiotics ('good' bacteria swallowed or sprayed into the nose) to pregnant women, new mothers and babies. These studies show that many probiotics are safe, but the amount of bacteria given is often unknown, and it is unclear if they work. A more precise option is to use controlled inoculation, by inserting a specific amount of particular 'good' bacteria into the nose under carefully controlled conditions. Our team have previously shown that inoculation with Neisseria lactamica ('good' bacteria) safely and reliably decreases Neisseria meningitidis ('bad' bacteria) in healthy adults' noses. N. lactamica is a type of harmless bacteria found in over 40% of children aged 1-2 years, but is uncommon in newborns and adults.
We plan to inoculate 20 healthy pregnant women with N. lactamica nose drops, to find out if it is transferred to their babies after birth. Newborns become rapidly covered (colonised) with bacteria from their mothers, other people, and the environment, so this method mimics a natural way that babies receive bacteria. We will take saliva and nose swabs one day, one week, one month and four months after birth, and will use microbiological and genetic methods to study how the bacteria changes in babies compared with their mothers.
Detailed description
We plan to perform nasal inoculation with N. lactamica (wild type strain Y92-1009) in healthy pregnant women, to establish whether horizontal N. lactamica transfer to their neonates occurs, and to characterise the impact on the developing neonatal upper respiratory tract (URT) microbiome. If successful, this study will provide a novel model for inducing and capturing a natural colonisation event in neonates. Unlike traditional controlled human infection models, which capture inoculation-induced colonisation, this first-in-man model would study person-to-person commensal transmission, allowing comparison of microbiome changes and adaptive commensal microevolution in mother-infant pairs. We have already conducted relevant Patient and Public Involvement research, in which all 12 pregnant women interviewed reported approval for this proposed study, and 11 expressed that they would have been interested in taking part in such a study.
We will approach healthy pregnant women in their second and third trimesters of pregnancy. Eligibility screening and enrolment will take place at 34+0 to 36+6 weeks gestation, and 20 women (not already colonised with N. lactamica) will be inoculated nasally with 10^5 colony forming units N. lactamica Y92-1009 at 36+0 to 37+6 weeks gestation. Samples will be obtained from new mothers (nasopharyngeal, oropharyngeal and saliva) and their neonates (nasopharyngeal and saliva) at 1 day, 1 week, 1 month and 4 months post-partum. If possible, and with the volunteer's consent, we will collect an umbilical cord blood sample at delivery and an infant venous blood sample at 1 month and 4 months post-partum, for storage and use in future studies. We will also collect a maternal venous blood sample at 4 months post-partum, as well as a saliva swab from any household contacts aged under 5 years. Any natural N. lactamica carriers identified at screening will not be inoculated, but will be followed-up with their neonates for biological sampling.
Pharyngeal and saliva swabs will be suspended in storage medium, aliquoted and stored at -80°C. N. lactamica colonisation will be confirmed using selective agar, Gram stain, microscopy, and analytical profile index testing (and matrix-assisted laser desorption/ionization time-of-flight for inconclusive results). N. lactamica colonisation density will be quantified, isolates will be stored at -80°C, and Y92-1009 strain identity will be confirmed using targeted polymerase chain reaction (PCR).
Microbiome analysis will be performed on thawed aliquots of paired mother-neonate samples, by DNA extraction, 16S ribosomal ribonucleic acid (rRNA) gene PCR, and amplicon sequencing. Poor quality and chimeric sequence reads will be removed, and high quality reads will be trimmed, aligned and clustered for taxonomic classification and statistical analysis.
Paired maternal and neonatal isolates confirmed as N. lactamica Y92-1009 will be sequenced, and resulting genomes will be mapped to a complete N. lactamica Y92-1009 closed reference genome, to assess for evidence of distinct microevolution.
We will also compare paired microbiome profiles to identify candidate organisms that are present in mothers and their infants. Paired mother-neonate sample aliquots will be thawed and plated onto selective media, and isolates of candidate species will be identified using Gram stain, microscopy, and other relevant microbiological tests. Resulting isolates will be sequenced and analysed for evidence of strain sharing between mothers and their neonates, suggesting horizontal transfer.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single intervention cohort will receive one open label intervention (nasal inoculation with 10^5 CFU N. lactamica). If any naturally-occurring N. lactamica carriers are identified at screening, they will not attend for inoculation with N. lactamica, but will be invited to remain in the study. They (and their neonates) will undergo the same follow-up visits and sampling as inoculated volunteers. This observational cohort is not considered a separate study arm, and there is no recruitment target for this cohort.
| Arm | Type | Receives |
|---|---|---|
| N. lactamica Y92-1009 | Experimental | Biological: N. lactamica Y92-1009Nasal inoculation with 10^5 CFU N. lactamica in 1ml phosphate-buffered saline via pipette to both nostrils; single inoculation at 36+0 to 37+6 weeks gestation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- All the following inclusion criteria must apply in order for the volunteer to be eligible for the study:
- Healthy adult aged 18 years or over on the day of enrolment.
- Singleton pregnancy, 34+0 to 36+6 weeks gestation on the day of enrolment.
- Documentation of a 20-week ultrasound scan with no life-limiting congenital anomalies, and no maxillofacial / otorhinolaryngological / neuroanatomical anomalies.
- Able and willing (in the Investigator's opinion) to comply with all study requirements.
Key exclusion criteria (12 listed)
- Any confirmed or suspected immunosuppressive or immunocompromised state, including: HIV infection; asplenia; recurrent severe infections; or use of immunosuppressant medication (for more than 14 days within the past 6 months, excluding topical and inhaled steroids).
- Planned use of immunosuppressant medication in later pregnancy or post-partum.
- Occupational, household or intimate contact with any immunosuppressed persons.
- Participation within the last 12 weeks in a clinical trial involving receipt of an investigational product, or planned use of an investigational product during the study period.
- Prior participation at any time in research studies involving inoculation with N. lactamica.
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 |
|---|---|---|
| N. lactamica Y92-1009Lyophilised N. lactamica reconstituted in phosphate-buffered saline | Biological | N. lactamica Y92-1009 |
Primary outcome
Neonatal N. lactamica colonisation
Time frame: Up to 4 weeks post-partum
Confirmation of neonatal (aged 0-30 days) N. lactamica colonisation by selective culture of biological (nasopharyngeal and/or saliva) samples
5 secondary outcomes
Adverse reactions or serious adverse events
Time frame: Enrolment (34+0 to 36+6 weeks gestation) to 4 weeks post-partum
Neonatal N. lactamica Y92-1009 colonisation
Time frame: Birth (0-24 hours post-partum), 7+/-3 days post-partum, 28+/-3 days post-partum
N. lactamica colonisation kinetics
Time frame: Birth (0-24 hours post-partum), 7+/-3 days post-partum, 28+/-3 days post-partum
Upper respiratory microbiome
Time frame: Birth (0-24 hours post-partum), 7+/-3 days post-partum, 28+/-3 days post-partum
N. lactamica Y92-1009 microevolution
Time frame: Birth (0-24 hours post-partum), 7+/-3 days post-partum, 28+/-3 days post-partum
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 6 Sep 2022.
- Derived from this study: PubMed 39986292Theodosiou AA, Bogaert D, Cleary DW, Dale AP, Gbesemete DF, Guy JM, Laver JR, Raud L, Jones CE, Read RC. Controlled human infection model of Neisseria lactamica in late pregnancy investigating mother-to-infant transmission in the UK: a single-arm pilot trial. Lancet Microbe. 2025 Apr;6(4):100986. doi: 10.1016/j.lanmic.2024.100986. Epub 2025 Feb 19.
- Derived from this study: PubMed 37463362Bevan JHJ, Theodosiou AA, Corner J, Dorey RB, Read RC, Jones CE. A Questionnaire-based Study Exploring Participant Perspectives in a Perinatal Human Challenge Trial. Pediatr Infect Dis J. 2023 Nov 1;42(11):935-941. doi: 10.1097/INF.0000000000004036. Epub 2023 Jul 18.
- Derived from this study: PubMed 35584870Theodosiou AA, Laver JR, Dale AP, Cleary DW, Jones CE, Read RC. Controlled human infection with Neisseria lactamica in late pregnancy to measure horizontal transmission and microbiome changes in mother-neonate pairs: a single-arm interventional pilot study protocol. BMJ Open. 2022 May 18;12(5):e056081. doi: 10.1136/bmjopen-2021-056081.
- 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.
Christine E Jones principal investigator
University of Southampton
Robert C Read principal investigator
University of Southampton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N. lactamica Y92-1009 in people with Microbial Colonization, run by University of Southampton at 1 site in United Kingdom.
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 7 inclusion and 12 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 6 Sep 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 United Kingdom. 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?
Neonatal N. lactamica colonisation (time frame: Up to 4 weeks post-partum). 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 NCT04784845, which also lists 3 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 6 Sep 2022.