Tracking the development of healthy infant gut bacteria in Bern
Official title: Bern Birth Cohort / Trajectory of Microbiota Maturation in Healthy Bern Infants - a Network Approach
Run by Insel Gruppe AG, University Hospital Bern · NCT04447742 · Data updated 2026-11-12
This study is looking at how healthy babies' gut bacteria grow and change during their first two years of life by following 250 pregnant moms and their kids for ten years.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 250 (estimated) |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 1 site (Bern) |
| Status | Recruiting |
| Started | May 7, 2020 |
| Main results expected | March 3, 2028 |
| Study ends | March 3, 2035 |
| Registry record updated | November 12, 2024 |
| Trial ID | NCT04447742 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are pregnant women aged 18-45 who are in good health and can provide informed consent.
✕Probably not a fit
Patients with severe medical or psychiatric conditions requiring ongoing management may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to understand how the intestinal microbiota of healthy infants matures over the first two years of life. Researchers will recruit 250 pregnant mothers and follow them and their infants until the children are 10 years old, analyzing various samples including stool, skin swabs, and maternal milk. Advanced techniques such as mass spectrometry and genomic sequencing will be employed to assess the composition and metabolic activities of the microbiota, as well as the impact of maternal factors and environment on this development.
Why it matters
Potential benefit: If successful, this study could provide insights into the factors that influence healthy gut microbiota development, potentially improving infant health outcomes.
How similar studies have gone: Other studies have shown success in understanding microbiota development, but this specific approach focusing on a network of maternal and infant factors is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Signed informed consent. * Ability to understand and follow study procedures and understand informed consent * From week 20 of pregnancy until birth * General good health, i.e. absence of major severe medical/ surgical/ psychiatric condition requiring ongoing management. Minor well controlled conditions (e.g. medically controlled arterial hypertension, occupational asthma, gestational diabetes mellitus) may be present. * Absence of known severe embryonal pathology, expected normal pregnancy (e.g. minor conditions including twin/ triplet pregnancy, final pelvic position may be present) * Age 18-45 years. Exclusion Criteria: • Participation in another clinical study interfering with study procedures.
Where it's running
-
University Hospital of Bern - Insel Spital
Bern, Switzerland Recruiting
Study contacts
- Principal investigator: Benjamin Misselwitz, Professor — University Hospital of Bern - Insel Spital
- Study coordinator: Benjamin Misselwitz, Professor
- Email: benjamin.misselwitz@insel.ch
- Phone: +41 31 664 04 30
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.