Studie PEARL-AGE. Vícegenerační přenos střevních bakterií a jeho stabilita v rodinách.
Vícegenerační přenos střevních bakterií a jeho stabilita v rodinách
Investigators will recruit up to 4-generations of human family cohorts, in order to characterize the microbiome and its changes across different generations.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní místa
-
-
Norfolk
-
Norwich, Norfolk, Spojené království, NR4 7UQ
- Quadram Institute Biosciences
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
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.
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: COHORT
- Časové perspektivy: PROSPECTIVE
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Characterizing microbial transfers in multigenerational families and subsequent stability of microbial colonization.
Časové okno: 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. |
2026
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Characterizing gut microbial evolution and adaptation in human host families.
Časové okno: 2026
|
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. |
2026
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Describing the prokaryotic and eukaryotic genome-level diversity within the human gut
Časové okno: 2024
|
Newly developed DNA extraction protocols for enrichment of specific microbial clades. |
2024
|
|
Identify predictors of within-family gut microbe transfer rates
Časové okno: 2026
|
Correlation coefficient of collected metadata (questionnaire derived) to observed shared microbes Correlate parallel colonization's of sibling to family questionnaire metadata (e.g. distances, closeness, habits, ..) Correlate genetic factors (immune system, etc) to microbial sharing/colonization rates |
2026
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Falk Hildebrand, PhD, Quadram Institute Bioscience
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- QIB01-2021
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .