HealthyPREVENTNCT06285630
The Development and Health of the Intestinal Flora During the First Year of Life
An observational study of Healthy and Microbial Colonization, run by Alba Health AB at 1 site in Sweden.
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… Read more about this study
- Who is it for?
- Ages 3 to 12 months
- Conditions the study is for
- Healthy, Microbial Colonization
- What is being tested?
- Observational, no intervation will be made
- How many people
- 300 participants
- Where
- 1 siteSweden
- Study dates
- 26 Feb 2024to 20 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 months
- All sexes
- Child
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.
Who may be able to join
- Healthy infants, no preterm and not undergoing antibiotic treatment
Who cannot join
- Preterm delivered infants or infants undergoing antibiotic treatment
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Observational, no intervation will be made
- Keywords
- Microbiome, Infant, healthy
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational, no intervation will be madeOther
No intervention will be made, only longitudinal sample collection.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Observational, no intervation will be made |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiome composition of infants in variable age ranges
How the microbiome changes according to age
Measured: 3 times points with 3 months in between time points
Secondary outcomes (1)
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.
Measured: 3 times points with 3 months in between time points
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start26 Feb 2024 (estimated)
- Primary completion30 Oct 2024 (estimated)
- Study completion20 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alba Health AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universiteit Antwerpen, Uppsala University, Copenhagen Studies on Asthma in Childhood
- Responsible party
- Sponsor
- Investigators
- Willem M de Vos, PhD, Principal investigator, Alba Health AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06285630
- Sponsor's protocol ID
- Alba101
- Other IDs
- 2023-05299-01, 2023
- Acronym
- PREVENT
- Status last verified
- Feb 2024
- First submitted
- 23 Feb 2024
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Publications
Orwa S, Vlajic M, Cavani E, Devall AE, Hugerth LW, Brusselaers N, De Vos WM. PREVENT 1, a nationwide Swedish infant cohort for longitudinal gut microbiome profiling and early-life health outcomes: cohort profile. BMJ Open. 2026 Aug 28;16(8):e118233. doi: 10.1136/bmjopen-2026-118233.
PubMed 42665338Cavani E, Edbom Devall A, Chen Y, Grompone G, Brusselaers N, Vlajic M, de Vos WM. Nationwide cohort study reveals low bifidobacteria and distinct microbiota composition and function in Swedish newborns. Gut Microbes. 2026 Dec 31;18(1):2719244. doi: 10.1080/19490976.2026.2719244. Epub 2026 Aug 26.
PubMed 42644416
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development and Health of the Intestinal Flora During the First Year of Life
- ClinicalTrials.gov ID
- NCT06285630
- Acronym / sponsor ID
- PREVENT / Alba101
- Conditions
- Healthy, Microbial Colonization
- Keywords
- Microbiome, Infant, healthy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Alba Health ABIndustry (pharma, biotech, devices)
- Collaborators
- Universiteit Antwerpen, Uppsala University, Copenhagen Studies on Asthma in Childhood
- Study start
- 26 Feb 2024 (estimated)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health infants | – | Other: Observational, no intervation will be madeWe 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. |
Who may qualify
- Ages
- 3 to 12 months
- Sex
- All
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- Healthy infants, no preterm and not undergoing antibiotic treatment
Key exclusion criteria (1 listed)
- Preterm delivered infants or infants undergoing antibiotic treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational, no intervation will be madeNo intervention will be made, only longitudinal sample collection. | Other | Health infants |
Primary outcome
Microbiome composition of infants in variable age ranges
Time frame: 3 times points with 3 months in between time points
How the microbiome changes according to age
1 secondary outcome
Is the composition associated with and gastrointestinal issues
Time frame: 3 times points with 3 months in between time points
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Derived from this study: PubMed 42665338Orwa S, Vlajic M, Cavani E, Devall AE, Hugerth LW, Brusselaers N, De Vos WM. PREVENT 1, a nationwide Swedish infant cohort for longitudinal gut microbiome profiling and early-life health outcomes: cohort profile. BMJ Open. 2026 Aug 28;16(8):e118233. doi: 10.1136/bmjopen-2026-118233.
- Derived from this study: PubMed 42644416Cavani E, Edbom Devall A, Chen Y, Grompone G, Brusselaers N, Vlajic M, de Vos WM. Nationwide cohort study reveals low bifidobacteria and distinct microbiota composition and function in Swedish newborns. Gut Microbes. 2026 Dec 31;18(1):2719244. doi: 10.1080/19490976.2026.2719244. Epub 2026 Aug 26.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Willem M de Vos, PhD principal investigator
Alba Health AB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Microbial Colonization, run by Alba Health AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiome composition of infants in variable age ranges (time frame: 3 times points with 3 months in between time points). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06285630, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.