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

NCT ID: NCT05346016

Last Updated: 2025-06-15

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-18
• Study Completion Date: 2026-03-31

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 persistence and dispersal to new human hosts is still surprisingly ill-defined.

Investigators hypothesize that some gut microbes persist over multiple generations and are adapted to varying degrees to their human hosts and families, making them potentially important members of the human gut. Bacterial strains can persist in the human host for years, with maternally-transferred strains known to persist longer in infants than environmentally acquired ones. It is conceivable that a given strain can colonize a host for several vertical generations, as already shown for Bifidobacterium using cultured isolates. Yet investigators currently lack knowledge of microbial persistence over multiple generations, and the proposed PEARL-AGE cohort is the first study investigating multi-generation persistence of gut bacteria (to our best knowledge).

The PEARL-AGE project will investigate microbial transfer and the evolution of microbes in family members from different generations. Investigators will recruit siblings, fathers/guardians, grandparents, and great-grandparents to fully capture vertical (between generations) and horizontal (same generation) microbial transmission across multiple generations, as well as tracking parallel microbial evolution in multiple family members. This will substantially increase our understanding of microbial transmission, long-term microbial persistence through generations and between cohabiting family members and siblings.

Conditions

Family Research

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Earlham Institute

UNKNOWN

Sponsor Role: collaborator

Norfolk and Norwich University Hospitals NHS Foundation Trust

OTHER

Sponsor Role: collaborator

Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)

OTHER

Sponsor Role: collaborator

Quadram Institute Bioscience

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Falk Hildebrand, PhD

Role: PRINCIPAL_INVESTIGATOR

Quadram Institute Bioscience

Locations

Quadram Institute Biosciences

Norwich, Norfolk, United Kingdom

Countries

United Kingdom

Other Identifiers

QIB01-2021

Identifier Type: -

Identifier Source: org_study_id