Status:
COMPLETED
Lactamica 9: Neisseria Lactamica Inoculation in Late Pregnancy
Lead Sponsor:
University of Southampton
Collaborating Sponsors:
University of Edinburgh
University Hospital Southampton NHS Foundation Trust
Conditions:
Microbial Colonization
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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...
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 cha...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
October 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 12 2022
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04784845
Start Date
October 1 2021
End Date
July 12 2022
Last Update
September 6 2022
Active Locations (1)
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1
University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom, SO166YD