The Pregnancy & Early Life Study (PEARL)
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|ClinicalTrials.gov Identifier: NCT03916874|
Recruitment Status : Enrolling by invitation
First Posted : April 16, 2019
Last Update Posted : December 11, 2019
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).
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||250 participants|
|Official Title:||A Longitudinal Study to Understand How Gut Microbes Contribute to Maintaining Health During Pregnancy and Early Life.|
|Actual Study Start Date :||April 12, 2019|
|Estimated Primary Completion Date :||June 2023|
|Estimated Study Completion Date :||June 2023|
Pregnant females and her newborn.
A longitudinal study of one cohort of 250 pregnant females less than 22 weeks gestation and her newborn. Swabs and samples (low vaginal, skin, urine, blood and stool) will be requested at one time point during each trimester from the participant. In addition, there are three different questionnaires at trimester 2.
- Microbial composition [ Time Frame: Baseline and 24 months (11 time points) ]Changes in microbiome measured by DNA/RNA sequencing of longitudinal samples from mothers and their babies.
- Microbial signatures identified and correlated with measures of health, host metabolites and immune markers. [ Time Frame: Baseline and 24 months (11 time points) ]Changes in microbial composition associated with diet (i.e. breast vs. formula feeding), drugs (i.e.antibiotics), and immune (i.e. cytokine) and metabolites markers measured in paired samples.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03916874
|Quadram Institute Bioscience|
|Norwich, Norfolk, United Kingdom, NR4 7UQ|
|Study Chair:||Lindsay Hall||Quadram Institute Bioscience|