Lactamica 9 (V1.1)
Research type
Research Study
Full title
Lactamica 9: Defining upper respiratory colonisation and microbiome evolution in mother-infant pairs following Neisseria lactamica inoculation in late pregnancy
IRAS ID
290865
Contact name
Christine E Jones
Contact email
Sponsor organisation
University of Southampton
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 9 months, 0 days
Research 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). 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 and one month after birth, and will use microbiological and genetic methods to study how the bacteria changes in babies compared with their mothers.
We have interviewed 12 pregnant women when designing this study, and found that they support this proposal. In the long term, the ultimate goal is to use ‘good’ bacteria to prevent ‘bad’ bacteria from colonising and causing disease, especially in the highest-risk first month of life.
REC name
London - Central Research Ethics Committee
REC reference
21/PR/0373
Date of REC Opinion
26 Apr 2021
REC opinion
Further Information Favourable Opinion