Actively Recruiting

Age: 18Years - 45Years
FEMALE
Healthy Volunteers
NCT04447742

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

Age: 18Years - 45Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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