Actively Recruiting
Bern Birth Cohort / Trajectory of Microbiota Maturation in Healthy Bern Infants - a Network Approach
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2024-11-12
250
Participants Needed
1
Research Sites
773 weeks
Total Duration
On this page
Sponsors
I
Insel Gruppe AG, University Hospital Bern
Lead Sponsor
U
University of Bern
Collaborating Sponsor
AI-Summary
What this Trial Is About
Background: Intestinal microbiota composition is fundamental to human health and undergoes critical changes within the first two years of life. Factors probably influencing the microbiota are the maternal microbiota and the general environment in Switzerland. However, the development of the intestinal microbiota is incompletely understood. Gaining knowledge of the trajectory of microbiota maturation is likely key to the understanding of the pathogenesis of many pathologies in childhood. Aims: The investigators aim for a deep understanding of the maturation of the healthy infant intestinal microbiota regarding composition, diversity and metabolic activities. The investigators aim for identifying parameters affecting microbiota maturation and effects of the microbiota on infant outcome. Methods: The investigators will recruit 250 pregnant mothers who will be followed as mother-baby pairs until 10 years of age. Infants will be followed clinically to determine adequate growth and development as well as pathology including abdominal pain. Epidemiological parameter and infant nutrition will be assessed. The investigators will collect biological samples such as stool, maternal milk, vaginal swaps and skin swaps. Species composition and diversity will be assessed by 16S sequencing. Metagenomic shotgun sequencing and bacterial messenger ribonucleic acid (mRNA) analysis will inform about metabolic potential and metabolic activity of the microbiota. Mass spectrometry will assess the small molecule content of stool and maternal milk samples. Network analysis will be used to assess the complex relationships between bacteria metabolic activities and small molecular content. Expected results: The investigators expect an increase in complexity and metabolic potential and activity with age. Microbiota parameters will differ according to nutrition and might predict infant outcomes such as growth and abdominal pain. Systematic analysis of sequential maternal and infant bacteria samples from stool, skin and maternal milk will help characterizing bacterial transfer from mother to infant Conclusion: The investigators propose an observational study of healthy Bern mother baby pairs with clinical characterisation and biological sampling. Advanced analysis tools will be used to characterise the microbiota and address mechanistic questions.
CONDITIONS
Official Title
Bern Birth Cohort / Trajectory of Microbiota Maturation in Healthy Bern Infants - a Network Approach
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Ability to understand and follow study procedures and informed consent
- Currently between week 20 of pregnancy and birth
- General good health without major severe medical, surgical, or psychiatric conditions needing ongoing treatment
- Minor well-controlled conditions such as controlled hypertension, occupational asthma, or gestational diabetes are allowed
- No known severe embryonal pathology and expected normal pregnancy (minor conditions like twins or final pelvic position allowed)
- Age between 18 and 45 years
You will not qualify if you...
- Participation in another clinical study that interferes with study procedures
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Hospital of Bern - Insel Spital
Bern, Switzerland, 3010
Actively Recruiting
Research Team
B
Benjamin Misselwitz, Professor
CONTACT
S
Stephanie Ganal-Vonarburg, Professor
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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