Family ResearchNCT05346016
The PEARL-AGE Study. Multigenerational Gut Bacteria Transmission and Its Stability in Families.
An observational study of Family Research, run by Quadram Institute Bioscience at 1 site in United Kingdom.
Trial summary
Investigators will recruit up to 4-generations of human family cohorts, in order to characterize the microbiome and its changes across different generations. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Family Research
- How many people
- 600 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Mar 2022to Mar 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Quadram Institute Biosciences
Norwich, Norfolk, NR4 7UQ
About this study
Official title: Multigenerational Gut Bacteria Transmission and Its Stability in Families
Investigators will recruit up to 4-generations of human family cohorts, in order to characterize the microbiome and its changes across different generations.
Read the 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
- Keywords
- gut microbiome, microbial adaptation, microbial evolution
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2026
Secondary outcomes (1)
Characterizing gut microbial evolution and adaptation in human host families.
Comparative genomics of metagenome assembled genomes (MAGs) per individual. Identifying newly introduced mutations in microbial genomes. Observing parallel evolution (e.g., loss or gain of the same genes in bacteria).
Associating human genotypes to microbial adaptation.
Measured: 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start18 Mar 2022
- Primary completionMar 2030 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family ResearchStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Quadram Institute Bioscience
- Sponsor type
- University, hospital or other
- Collaborators
- Earlham Institute, Norfolk and Norwich University Hospitals NHS Foundation Trust, Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
- Responsible party
- Sponsor
- Investigators
- Falk Hildebrand, PhD, Principal investigator, Quadram Institute Bioscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05346016
- Sponsor's protocol ID
- QIB01-2021
- Status last verified
- Aug 2026
- First submitted
- 20 Apr 2022
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multigenerational Gut Bacteria Transmission and Its Stability in Families
- ClinicalTrials.gov ID
- NCT05346016
- Acronym / sponsor ID
- QIB01-2021
- Conditions
- Family Research
- Keywords
- gut microbiome, microbial adaptation, microbial evolution
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Quadram Institute BioscienceUniversity, hospital or other
- Collaborators
- Earlham Institute, Norfolk and Norwich University Hospitals NHS Foundation Trust, Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
- Study start
- 18 Mar 2022 (actual)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- The following relations of the PEARL mother/baby are eligible for inclusion:
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characterizing microbial transfers in multigenerational families and subsequent stability of microbial colonization.
Time frame: 2026
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.
1 secondary outcome
Characterizing gut microbial evolution and adaptation in human host families.
Time frame: 2026
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Falk Hildebrand, PhD principal investigator
Quadram Institute Bioscience
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Family Research, run by Quadram Institute Bioscience at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterizing microbial transfers in multigenerational families and subsequent stability of microbial colonization. (time frame: 2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.