MedDataX Logo

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

NCT ID: NCT06285630

Last Updated: 2024-02-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-26

Study Completion Date

2024-12-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Microbial Colonization

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Microbiome, Infant, healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Observational, no intervation will be made

Intervention Type OTHER

No intervention will be made, only longitudinal sample collection.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Observational, no intervation will be made

No intervention will be made, only longitudinal sample collection.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy infants, no preterm and not undergoing antibiotic treatment

Exclusion Criteria

* Preterm delivered infants or infants undergoing antibiotic treatment
Minimum Eligible Age

3 Months

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universiteit Antwerpen

OTHER

Sponsor Role collaborator

Uppsala University

OTHER

Sponsor Role collaborator

Copenhagen Studies on Asthma in Childhood

OTHER

Sponsor Role collaborator

Alba Health AB

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Willem M de Vos, PhD

Role: PRINCIPAL_INVESTIGATOR

Alba Health AB

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Alba Health AB

Stockholm, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2023-05299-01

Identifier Type: OTHER

Identifier Source: secondary_id

Alba101

Identifier Type: -

Identifier Source: org_study_id