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

Healthy Clinical Trial

— PREVENT  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06285630
• Other study ID #: Alba101
• Secondary ID: 2023-05299-01
• Status: Enrolling by invitation
• Start date: February 26, 2024
• Est. completion date: December 20, 2024

Study information

• Verified date: February 2024
• Source: Alba Health AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: December 20, 2024
• Est. primary completion date: October 30, 2024
• Gender: All
• Age group: 3 Months to 12 Months

Eligibility

Inclusion Criteria:

• Healthy infants, no preterm and not undergoing antibiotic treatment

Exclusion Criteria:

• Preterm delivered infants or infants undergoing antibiotic treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Healthy
• Infections
• Microbial Colonization

Intervention

Other:
• Observational, no intervation will be made
No intervention will be made, only longitudinal sample collection.

Locations

Country	Name	City	State
Sweden	Alba Health AB	Stockholm

Sponsors (4)

Lead Sponsor	Collaborator
Alba Health AB	Copenhagen Studies on Asthma in Childhood, Universiteit Antwerpen, Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbiome composition of infants in variable age ranges	How the microbiome changes according to age	3 times points with 3 months in between time points
Secondary	Is the composition associated with and gastrointestinal issues	How the microbiome composition in different ages can be associated with different GIT disturbances in infants between 3 and 12 months of age.	3 times points with 3 months in between time points