Clinical Trials in Switzerland / NCT04447742
Recruiting
Observational
Bern Birth Cohort / Trajectory of Microbiota Maturation in Healthy Bern Infants - a Network Approach
NCT04447742 · tracked via the Priya Life Science Switzerland tracker
Condition(s) studied
Maturation of the Healthy Infant Intestinal MicrobiotaMicrobial ColonizationNutrition Disorder, InfantMilk Expression, BreastMental Health Disorder
Study 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
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.
Primary outcome measure(s)
- Maturation of a healthy infant intestinal microbiota regarding complexity of species composition and metabolic activities. — Infant stool samples will be collected 0-3 days after birth
The investigators are aiming for a deep understanding of the maturation of a healthy infant intestinal microbiota considering composition, diversity and metabolic activities. The investigators will characterise the composition, metabolic potential and activity at various time points by advanced techniques (16S sequencing, metagenomics shotgun sequencing and mRNA sequencing) and the metabolites present by mass spectrometry (see "detailed description") . Using this information, the investigators will estimate networks of metabolic activity of the microbiota. Network analysis can be informed by information regarding small molecules present. The trajectories shared by the microbiota of most healthy infants will be considered normal. - Maturation of a healthy infant intestinal microbiota regarding complexity of species composition and metabolic activities. — Infant stool samples will be collected 10 days after birth
The investigators are aiming for a deep understanding of the maturation of a healthy infant intestinal microbiota considering composition, diversity and metabolic activities. The investigators will characterise the composition, metabolic potential and activity at various time points by advanced techniques (16S sequencing, metagenomics shotgun sequencing and mRNA sequencing) and the metabolites present by mass spectrometry (see "detailed description") . Using this information, the investigators will estimate networks of metabolic activity of the microbiota. Network analysis can be informed by information regarding small molecules present. The trajectories shared by the microbiota of most healthy infants will be considered normal. - Maturation of a healthy infant intestinal microbiota regarding complexity of species composition and metabolic activities. — Infant stool samples will be collected 6 weeks after birth
The investigators are aiming for a deep understanding of the maturation of a healthy infant intestinal microbiota considering composition, diversity and metabolic activities. The investigators will characterise the composition, metabolic potential and activity at various time points by advanced techniques (16S sequencing, metagenomics shotgun sequencing and mRNA sequencing) and the metabolites present by mass spectrometry (see "detailed description") . Using this information, the investigators will estimate networks of metabolic activity of the microbiota. Network analysis can be informed by information regarding small molecules present. The trajectories shared by the microbiota of most healthy infants will be considered normal. - Maturation of a healthy infant intestinal microbiota regarding complexity of species composition and metabolic activities. — Infant stool samples will be collected 10 weeks after birth
The investigators are aiming for a deep understanding of the maturation of a healthy infant intestinal microbiota considering composition, diversity and metabolic activities. The investigators will characterise the composition, metabolic potential and activity at various time points by advanced techniques (16S sequencing, metagenomics shotgun sequencing and mRNA sequencing) and the metabolites present by mass spectrometry (see "detailed description") . Using this information, the investigators will estimate networks of metabolic activity of the microbiota. Network analysis can be informed by information regarding small molecules present. The trajectories shared by the microbiota of most healthy infants will be considered normal. - Maturation of a healthy infant intestinal microbiota regarding complexity of species composition and metabolic activities. — Infant stool samples will be collected 14 weeks after birth
The investigators are aiming for a deep understanding of the maturation of a healthy infant intestinal microbiota considering composition, diversity and metabolic activities. The investigators will characterise the composition, metabolic potential and activity at various time points by advanced techniques (16S sequencing, metagenomics shotgun sequencing and mRNA sequencing) and the metabolites present by mass spectrometry (see "detailed description") . Using this information, the investigators will estimate networks of metabolic activity of the microbiota. Network analysis can be informed by information regarding small molecules present. The trajectories shared by the microbiota of most healthy infants will be considered normal. - Maturation of a healthy infant intestinal microbiota regarding complexity of species composition and metabolic activities. — Infant stool samples will be collected 24 weeks after birth
The investigators are aiming for a deep understanding of the maturation of a healthy infant intestinal microbiota considering composition, diversity and metabolic activities. The investigators will characterise the composition, metabolic potential and activity at various time points by advanced techniques (16S sequencing, metagenomics shotgun sequencing and mRNA sequencing) and the metabolites present by mass spectrometry (see "detailed description") . Using this information, the investigators will estimate networks of metabolic activity of the microbiota. Network analysis can be informed by information regarding small molecules present. The trajectories shared by the microbiota of most healthy infants will be considered normal. - Maturation of a healthy infant intestinal microbiota regarding complexity of species composition and metabolic activities. — Infant stool samples will be collected 36 weeks after birth
The investigators are aiming for a deep understanding of the maturation of a healthy infant intestinal microbiota considering composition, diversity and metabolic activities. The investigators will characterise the composition, metabolic potential and activity at various time points by advanced techniques (16S sequencing, metagenomics shotgun sequencing and mRNA sequencing) and the metabolites present by mass spectrometry (see "detailed description") . Using this information, the investigators will estimate networks of metabolic activity of the microbiota. Network analysis can be informed by information regarding small molecules present. The trajectories shared by the microbiota of most healthy infants will be considered normal. - Maturation of a healthy infant intestinal microbiota regarding complexity of species composition and metabolic activities. — Infant stool samples will be collected 48 weeks after birth
The investigators are aiming for a deep understanding of the maturation of a healthy infant intestinal microbiota considering composition, diversity and metabolic activities. The investigators will characterise the composition, metabolic potential and activity at various time points by advanced techniques (16S sequencing, metagenomics shotgun sequencing and mRNA sequencing) and the metabolites present by mass spectrometry (see "detailed description") . Using this information, the investigators will estimate networks of metabolic activity of the microbiota. Network analysis can be informed by information regarding small molecules present. The trajectories shared by the microbiota of most healthy infants will be considered normal. - Maturation of a healthy infant intestinal microbiota regarding complexity of species composition and metabolic activities. — Infant stool samples will be collected 96 weeks after birth
The investigators are aiming for a deep understanding of the maturation of a healthy infant intestinal microbiota considering composition, diversity and metabolic activities. The investigators will characterise the composition, metabolic potential and activity at various time points by advanced techniques (16S sequencing, metagenomics shotgun sequencing and mRNA sequencing) and the metabolites present by mass spectrometry (see "detailed description") . Using this information, the investigators will estimate networks of metabolic activity of the microbiota. Network analysis can be informed by information regarding small molecules present. The trajectories shared by the microbiota of most healthy infants will be considered normal. - Maturation of a healthy infant intestinal microbiota regarding complexity of species composition and metabolic activities. — Infant stool samples will be collected 5 years after birth
The investigators are aiming for a deep understanding of the maturation of a healthy infant intestinal microbiota considering composition, diversity and metabolic activities. The investigators will characterise the composition, metabolic potential and activity at various time points by advanced techniques (16S sequencing, metagenomics shotgun sequencing and mRNA sequencing) and the metabolites present by mass spectrometry (see "detailed description") . Using this information, the investigators will estimate networks of metabolic activity of the microbiota. Network analysis can be informed by information regarding small molecules present. The trajectories shared by the microbiota of most healthy infants will be considered normal. - Maturation of a healthy infant intestinal microbiota regarding complexity of species composition and metabolic activities. — Infant stool samples will be collected 10 years after birth
The investigators are aiming for a deep understanding of the maturation of a healthy infant intestinal microbiota considering composition, diversity and metabolic activities. The investigators will characterise the composition, metabolic potential and activity at various time points by advanced techniques (16S sequencing, metagenomics shotgun sequencing and mRNA sequencing) and the metabolites present by mass spectrometry (see "detailed description") . Using this information, the investigators will estimate networks of metabolic activity of the microbiota. Network analysis can be informed by information regarding small molecules present. The trajectories shared by the microbiota of most healthy infants will be considered normal.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| University Hospital of Bern - Insel Spital | Bern | Switzerland | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04447742 on ClinicalTrials.gov ↗ ← All trials in Switzerland