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The Pregnancy & Early Life Study (PEARL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03916874
Recruitment Status : Enrolling by invitation
First Posted : April 16, 2019
Last Update Posted : December 11, 2019
Sponsor:
Collaborators:
Norfolk and Norwich University Hospitals NHS Foundation Trust
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Quadram Institute Bioscience

Brief 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).


Condition or disease
Pregnancy

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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
faeces, urine, skin swabs, vaginal swabs, breast milk (optional), blood (optional)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant females less than 22 weeks gestation.
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
250 pregnant healthy females less than 22 weeks gestation, paired with her newborn baby/babies.
Criteria

Inclusion Criteria:

  • All participants must be able to understand the requirements of the study and provide signed and dated informed consent for herself and her unborn child.
  • Planning to give birth at NNUH or at home.
  • At the point of study consent, be ≤22 weeks pregnant.
  • BMI between ≥18 - ≤35 kg/m2.
  • Must be willing to provide biological samples over a period of 31 months (urine samples, stool samples, low vaginal swabs, skin swabs and breast milk (if breastfeeding this is optional). Blood samples are optional.
  • Must be willing to accommodate a small freezer to store frozen samples for the duration of the study.
  • Must be willing to complete study questionnaires over a period of 31 months.

Exclusion Criteria:

The participant may not enter the study if ANY of the following apply:

  • Pregnancy is for surrogacy purposes.
  • Planned adoption, fostering of baby or baby not planned to be living with biological mother.
  • Currently taking part in an interventional study.
  • Living with or related to a member of the Research Study team.
  • Current smoker.
  • Taken antibiotics or antifungals or antivirals within the last 3 months. Taken steroids within the last 6 months.
  • Currently taking more than a daily dose of probiotics. Have a history of polyps within the gut.
  • Have a long-standing gastrointestinal or liver function abnormality requiring on-going medical management or medication.
  • Current or history of cancer except for squamous or basal cell carcinomas of the skin that have been medically managed by local excision.
  • Unstable dietary history as defined by major changes in diet during the previous month, where participants have stopped or significantly increased a major food group in the diet, for example changed to vegan, vegetarian or stopped eating red meat.
  • History of alcohol, drug or substance abuse. Have a history of Hepatitis B or Hepatitis C.
  • Any confirmed or suspected pre-existing condition/state of immunosuppression or immunodeficiency (primary or acquired), for example Rheumatoid Arthritis, Type 1 Diabetes, Multiple Sclerosis, Asthma, Eczema and Psoriasis. (Participants who are asymptomatic of Asthma, Eczema and Psoriasis in the last 5 years can be included in the study).
  • Major surgery of the gastrointestinal tract, apart from gall bladder or appendix removal, in the past five years.
  • Any major bowel resection at any time.
  • History of Ulcerative Colitis or Crohn's Disease or Diverticulitis.
  • Persistent, infectious gastroenteritis, gastritis, persistent or chronic diarrhoea of unknown cause, Clostridium difficile infection (recurrent) or Helicobacter pylori infection (untreated).
  • Chronic constipation.

Information from the National Library of Medicine

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


Locations
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United Kingdom
Quadram Institute Bioscience
Norwich, Norfolk, United Kingdom, NR4 7UQ
Sponsors and Collaborators
Quadram Institute Bioscience
Norfolk and Norwich University Hospitals NHS Foundation Trust
National Institute for Health Research, United Kingdom
Investigators
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Study Chair: Lindsay Hall Quadram Institute Bioscience
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Responsible Party: Quadram Institute Bioscience
ClinicalTrials.gov Identifier: NCT03916874    
Other Study ID Numbers: QIB02/2018
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: December 11, 2019
Last Verified: December 2019