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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Healthy; Microbial Colonization
• Intervention / Treatment: Other: Observational, no intervation will be made

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Alba Health AB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: N/A

• 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.

Description

Inclusion Criteria:

• Healthy infants, no preterm and not undergoing antibiotic treatment

Exclusion Criteria:

• Preterm delivered infants or infants undergoing antibiotic treatment

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; No intervention will be made, only longitudinal sample collection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Alba Health AB
• Collaborators: Uppsala University; Universiteit Antwerpen; Copenhagen Studies on Asthma in Childhood
• Investigators: Principal Investigator: Willem M de Vos, PhD, Alba Health AB

Study record dates

Study Major Dates

• Study Start (Estimated): February 26, 2024
• Primary Completion (Estimated): October 30, 2024
• Study Completion (Estimated): December 20, 2024

Study Registration Dates

• First Submitted: February 23, 2024
• First Submitted That Met QC Criteria: February 23, 2024
• First Posted (Estimated): February 29, 2024

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Microbiome, Infant, healthy
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: Alba101; 2023-05299-01 (Other Identifier: Ethix)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We will make the metagenomic sequences publicly available upon publication as required by all scientific journals but no other IPD will be published in line with the GDPR requirements

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No