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

NCT06285630 | Enrolling By Invitation

• 2 other identifiers: Alba1012023-05299-01
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Microbial Colonization

Keywords

Microbiome, Infant, healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Is the composition associated with and gastrointestinal issues

  3 times points with 3 months in between time points

Study Arms (1)

Health infants

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.

Other: Observational, no intervation will be made

Interventions

Observational, no intervation will be made OTHER

No intervention will be made, only longitudinal sample collection.

Health infants

Eligibility Criteria

• Age: 3 Months - 12 Months
• Sex: all
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Healthy infants, no preterm and not undergoing antibiotic treatment

You may not qualify if:

• Preterm delivered infants or infants undergoing antibiotic treatment

Sponsors & Collaborators

• Alba Health AB: lead
• Universiteit Antwerpen: collaborator
• Uppsala University: collaborator
• Copenhagen Studies on Asthma in Childhood: collaborator

Study Sites (1)

Alba Health AB

Stockholm, Sweden

Location

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Willem M de Vos, PhD

  Alba Health AB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: February 29, 2024
• Study Start: February 26, 2024
• Primary Completion: October 30, 2024
• Study Completion: December 20, 2024
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)