The PEARL-AGE Study. Multigenerational Gut Bacteria Transmission and Its Stability in Families. (NCT05346016) | Clinical Trial Compass
By InvitationNot Applicable
The PEARL-AGE Study. Multigenerational Gut Bacteria Transmission and Its Stability in Families.
United Kingdom600 participantsStarted 2022-03-18
Plain-language summary
Investigators will recruit up to 4-generations of human family cohorts, in order to characterize the microbiome and its changes across different generations.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 If a PEARL participant has withdrawn from the PEARL study or is no longer participating, investigators will not approach the PEARL participant for recruitment of their family members.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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Characterizing microbial transfers in multigenerational families and subsequent stability of microbial colonization.