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The Development and Health of the Intestinal Flora During the First Year of Life

The Development and Health of the Intestinal Flora During the First Year of Life

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06285630
Acronym
PREVENT
Enrollment
300
Registered
2024-02-29
Start date
2024-02-26
Completion date
2024-12-20
Last updated
2024-02-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Microbial Colonization

Keywords

Microbiome, Infant, healthy

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 study's 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.

Interventions

OTHERObservational, no intervation will be made

No intervention will be made, only longitudinal sample collection.

Sponsors

Universiteit Antwerpen
CollaboratorOTHER
Uppsala University
CollaboratorOTHER
Copenhagen Studies on Asthma in Childhood
CollaboratorOTHER
Alba Health AB
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Months to 12 Months

Inclusion criteria

* Healthy infants, no preterm and not undergoing antibiotic treatment

Exclusion criteria

* Preterm delivered infants or infants undergoing antibiotic treatment

Design outcomes

Primary

MeasureTime frameDescription
Microbiome composition of infants in variable age ranges3 times points with 3 months in between time pointsHow the microbiome changes according to age

Secondary

MeasureTime frameDescription
Is the composition associated with and gastrointestinal issues3 times points with 3 months in between time pointsHow the microbiome composition in different ages can be associated with different GIT disturbances in infants between 3 and 12 months of age.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 27, 2026