Tracking the development of healthy infant gut bacteria in Bern
Bern Birth Cohort / Trajectory of Microbiota Maturation in Healthy Bern Infants - a Network Approach
Insel Gruppe AG, University Hospital Bern · NCT04447742
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 |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Insel Gruppe AG, University Hospital Bern (other) |
| Locations | 1 site (Bern) |
| Trial ID | NCT04447742 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 18-45 who are in good health and can provide informed consent.
Not a fit: Patients with severe medical or psychiatric conditions requiring ongoing management may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bern
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Maturation of the Healthy Infant Intestinal Microbiota, Microbial Colonization, Nutrition Disorder, Infant, Milk Expression, Breast, Mental Health Disorder