The Pregnancy & Early Life Study

The gut is home to a diverse and dynamic microbial community, termed the microbiota. The microbiota is essential for health and wellbeing and is involved in acquisition of nutrients and energy from the diet, optimisation of the immune system, and resistance against invading pathogens. Critically, in both new mothers and their babies, any disturbance of the microbiota (caused, for example, by antibiotics, delivery mode \[vaginal/Caesarean section\], or dietary change), has the potential to increase the risk that the baby might subsequently develop allergic-type disorders, infections, and chronic intestinal diseases. Early life is a key period of development, but the investigators need a clearer understanding of how maternal factors and transmission of beneficial microbes from mother to baby influence the development of a healthy infant microbiota. This is only possible through longitudinal studies, where the profiles of microbiota from cohorts of mothers and their babies are correlated with routine and more specific clinical data (i.e. antibiotics and diet) throughout pregnancy and into early life. In order to achieve the aims of the study, the Quadram Institute Bioscience (QIB) will work in collaboration with the Norfolk \& Norwich University Hospital (NNUH) to recruit 250 pregnant female participants. Study duration will be approximately 31 months and during this time, the investigators will ask the participants to collect urine and stool samples and low vaginal and skin swabs. Blood samples and breast milk are optional. From her newborn, investigators will ask the participant to collect a meconium and stool samples and skin swabs. The participant will complete three different types of questionnaires for herself and her newborn over 31 months. This study is fully funded by the Biotechnology and Biological Sciences Research Council (BBSRC).

NCT Number	NCT03916874
Lead Sponsor	Quadram Institute Bioscience Collaborators: Norfolk and Norwich University Hospitals NHS Foundation Trust, National Institute for Health Research, United Kingdom
Conditions	Pregnancy
Enrollment	261 participants
Start Date	2019-05-01
Primary Completion	2025-12-01 (estimated)
Study Completion	2025-12-01 (estimated)
Updated on ClinicalTrials.gov	2025-03-20