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The Pregnancy & Early Life Study

NCT03916874 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 261

Last updated 2025-03-20

No results posted yet for this study

Summary

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).

Conditions

  • Pregnancy

Sponsors & Collaborators

  • Norfolk and Norwich University Hospitals NHS Foundation Trust

    collaborator OTHER

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV

  • Quadram Institute Bioscience

    lead OTHER

Principal Investigators

  • Lindsay Hall · Quadram Institute Bioscience

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2025-12-01
Completion
2025-12-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03916874 on ClinicalTrials.gov