NCT04447742 Bern Birth Cohort / Trajectory of Microbiota Maturation in Healthy Bern Infants - a Network Approach
| NCT ID | NCT04447742 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | Maturation of the Healthy Infant Intestinal Microbiota |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2020-05-07 |
| Primary Completion | 2028-03-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2020-05-07 with a primary completion date of 2028-03-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Benjamin Misselwitz, Professor
PRINCIPAL INVESTIGATOR
University Hospital of Bern - Insel Spital
Frequently Asked Questions
Who can join the NCT04447742 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Maturation of the Healthy Infant Intestinal Microbiota. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04447742 currently recruiting?
Yes, NCT04447742 is actively recruiting participants. Contact the research team at benjamin.misselwitz@insel.ch for enrollment information.
Where is the NCT04447742 trial being conducted?
This trial is being conducted at Bern, Switzerland.
Who is sponsoring the NCT04447742 clinical trial?
NCT04447742 is sponsored by Insel Gruppe AG, University Hospital Bern. The principal investigator is Benjamin Misselwitz, Professor at University Hospital of Bern - Insel Spital. The trial plans to enroll 250 participants.