Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06285630
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-02-29
First Post:
2024-02-23
Brief Title:
The Development and Health of the Intestinal Flora During the First Year of Life
Sponsor:
Alba Health AB
Organization:
Alba Health AB
Study Overview
Official Title:
The Development and Health of the Intestinal Flora During the First Year of Life
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREVENT
Brief Summary:
In this research study PREVENT 1 Alba Health in collaboration with academic institutions Uppsala University COPSAC and University of Antwerp is investigating the association between the developing gut microbiota collection of microbes present in the human gut in the first year of life and lifestyle wellbeing and health in a Swedish population The study is the first of its kind in a Swedish population to collect and associate microbiome composition to an extensive family history and health questionnaire stool colour and crying type building on learnings from previous studies performed in other countries such as the HELMI and COPSAC studies HELMI - Finnish Health and Early Life Microbiota cohort from the University of Helsinki in Finland COPSAC - Copenhagen Prospective Studies on Asthma in Childhood in Denmark
The PREVENT 1 study is an observational research study led by Alba Health involving 300 families in Sweden with children between 0 and 12 months of age at the time of the studys start After providing informed consent the participating families will be asked to provide three stool samples from their child the sample collection is not invasive and does not cause discomfort and will be asked to answer questionnaires on lifestyle well-being and family health The participating families will not be asked to change their lifestyle beyond sample and data collection
From the collected stool samples we will extract microbial DNA and subject this to deep metagenomic sequence analysis The study will only analyze microbial DNA any human related material will be discarded The stool samples will be destroyed within one month of sequencing maximum 3 months from collection The data will be stored according to GDPR and Swedish law with informed consent in Sweden and with appropriate security measures All research will be carried out in Sweden
The PREVENT 1 study is an observational research study led by Alba Health involving 300 families in Sweden with children between 0 and 12 months of age at the time of the studys start After providing informed consent the participating families will be asked to provide three stool samples from their child the sample collection is not invasive and does not cause discomfort and will be asked to answer questionnaires on lifestyle well-being and family health The participating families will not be asked to change their lifestyle beyond sample and data collection
From the collected stool samples we will extract microbial DNA and subject this to deep metagenomic sequence analysis The study will only analyze microbial DNA any human related material will be discarded The stool samples will be destroyed within one month of sequencing maximum 3 months from collection The data will be stored according to GDPR and Swedish law with informed consent in Sweden and with appropriate security measures All research will be carried out in Sweden
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-05299-01 | OTHER | Ethix | None |