Status:

ENROLLING_BY_INVITATION

The PEARL-AGE Study. Multigenerational Gut Bacteria Transmission and Its Stability in Families.

Lead Sponsor:

Quadram Institute Bioscience

Collaborating Sponsors:

Earlham Institute

Norfolk and Norwich University Hospitals NHS Foundation Trust

Conditions:

Family Research

Eligibility:

All Genders

Brief Summary

Investigators will recruit up to 4-generations of human family cohorts, in order to characterize the microbiome and its changes across different generations.

Detailed Description

Interest in the gut microbiome from both the scientific community and public has increased exponentially over the last decade. Yet our knowledge of the microbes in the gut microbiome, their persistenc...

Eligibility Criteria

Inclusion

  • The following relations of the PEARL mother/baby are eligible for inclusion:
  • Husband/partner of a PEARL mother, their biological parents and grandparents.
  • PEARL mother's biological parents and grandparents (great-grandparents to the PEARL baby).
  • Co-habiting non-biological fathers of the baby such as stepfathers and partners of the PEARL mother, their parents and grandparents.
  • A biological sibling of the PEARL baby or a step-sibling who is currently co-habiting with the PEARL baby.
  • Adult participants must be able to consent for themselves and able to understand the questionnaire.
  • Child participants must have a parent and/or guardian to provide assent on their behalf.
  • Must be living in England.
  • Must be willing to accommodate a small cool box to store and transport the biological samples until they are collected, if not having immediate access to the PEARL study freezer.
  • Vulnerable participants such as participants with mild cognitive impairment may be included as long as they have full support from their family members.

Exclusion

  • Not related/affiliated to a mother currently participating in the PEARL study, or the cohabiting partner, or father of the PEARL infant. If a PEARL participant has withdrawn from the PEARL study or is no longer participating, investigators will not approach the PEARL participant for recruitment of their family members.
  • Step-fathers or long-term partners that have been cohabiting with the PEARL mother for less than three months.
  • Those currently in prison.
  • Those who are unable to provide written informed consent.
  • Living with or related to a member of the Research Study team.

Key Trial Info

Start Date :

March 18 2022

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

March 1 2026

Estimated Enrollment :

600 Patients enrolled

Trial Details

Trial ID

NCT05346016

Start Date

March 18 2022

End Date

March 1 2026

Last Update

June 15 2025

Active Locations (1)

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Quadram Institute Biosciences

Norwich, Norfolk, United Kingdom, NR4 7UQ