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

NCT05346016 | Enrolling By Invitation

• 1 other identifier: QIB01-2021
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Family Research

Keywords

gut microbiome; microbial adaptation; microbial evolution

Outcome Measures

Primary Outcomes (1)

• Characterizing microbial transfers in multigenerational families and subsequent stability of microbial colonization.

  High-resolution metagenomics of strains tracked over time in individuals and families, relative to collected metadata (family closeness, medical history, etc) Associating microbiome stability to human genetic loci.

  2026

Secondary Outcomes (1)

• Characterizing gut microbial evolution and adaptation in human host families.

  2026

Other Outcomes (2)

• Describing the prokaryotic and eukaryotic genome-level diversity within the human gut

  2024

• Identify predictors of within-family gut microbe transfer rates

  2026

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Investigators are recruiting the family members of PEARL (ClinicalTrials.gov ID: NCT03916874) study participants, a longitudinal study to understand how gut microbes contribute to maintaining health during pregnancy and early life already underway at QIB (Quadram Institute Bioscience). Investigators will extend this cohort, by recruiting family members of the PEARL mother to form the PEARL-AGE cohort, extending it from two generations to four generations.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Quadram Institute Bioscience: lead
• Earlham Institute: collaborator
• Norfolk and Norwich University Hospitals NHS Foundation Trust: collaborator
• Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK): collaborator

Study Sites (1)

Quadram Institute Biosciences

Norwich, Norfolk, NR4 7UQ, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Faecal samples will be collected from the participants.

Study Officials

• Falk Hildebrand, PhD

  Quadram Institute Bioscience

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2022
• First Posted: April 26, 2022
• Study Start: March 18, 2022
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: June 15, 2025

Record last verified: 2025-06

Locations

GB (1)