Clinical trial NCT06285630: The Development and Health of the Intestinal Flora During the First Year of Life
Official title: The Development and Health of the Intestinal Flora During the First Year of Life
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Healthy
Microbial Colonization
Keywords: Microbiome, Infant, healthy
Lead sponsor: Alba Health AB
Sponsor class: INDUSTRY
Collaborators: name: Universiteit Antwerpen
name: Uppsala University
name: Copenhagen Studies on Asthma in Childhood
First posted: 2024-02-29
Enrollment: 300
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We aim to recruit parents of infants in an age range between 3 and 12 months. Healthy infants only, which were delivered in term and that are not undergoing any antibiotic treatment.

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.


Eligibility criteria: Inclusion Criteria:

* Healthy infants, no preterm and not undergoing antibiotic treatment

Exclusion Criteria:

* Preterm delivered infants or infants undergoing antibiotic treatment

Primary outcomes:
measure: Microbiome composition of infants in variable age ranges
timeFrame: 3 times points with 3 months in between time points
Secondary outcomes:
measure: Is the composition associated with and gastrointestinal issues
timeFrame: 3 times points with 3 months in between time points
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Alba Health AB
Study officials:
affiliation: Alba Health AB
name: Willem M de Vos, PhD
role: PRINCIPAL_INVESTIGATOR
References: