Ignite Creation Date:
2024-05-06 @ 2:51 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04447742
Status:
RECRUITING
Last Update Posted:
2023-03-02
First Post:
2020-05-19
Brief Title:
Bern Birth Cohort Trajectory of Microbiota Maturation in Healthy Bern Infants - a Network Approach
Sponsor:
Insel Gruppe AG University Hospital Bern
Organization:
Insel Gruppe AG University Hospital Bern
Study Overview
Official Title:
Bern Birth Cohort Trajectory of Microbiota Maturation in Healthy Bern Infants - a Network Approach
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BeBiCo
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
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
Detailed Description:
Methods for sample analysis
For the primary objective and outcome endpoint of the study bacterial content of infant stool will be analyzed by
Mass spectrometry to assess intestinal content metabolome Techniques have been established in the laboratory of Prof U Sauer who already collaborated with the investigators group in previous studies
16S ribosomal ribonucleic acid rRNA sequencing for bacterial species composition as well as microbial diversity
Bacterial full genome metagenomics shotgun sequencing to identify bacterial genes present metabolic potential of the microbiota
Bacterial mRNA sequencing to assess transcription and a functional role of the microbiota metabolic activity of microbiota
Analysis of the intestinal virome and eukaryotic intestinal populations by appropriate sequencing or culturing techniques
Analysis of IgA antibodies in human milk and stool and the interaction of antibodies with intestinal bacteria
For the secondary endpoints identical analyses will be performed in skin swabs maternal milk maternal vaginal swabs and maternal stool Parameters for infant growth neurodevelopment immune maturation and potential occurrence of pathology will be assessed at every visit Maternal and infant nutrition hygiene socioeconomic status and clinical history will be assessed by questionnaires at every visit Milk samples will further be analyzed for their cellular contents by flow cytometry and single cell RNA-sequencing as well as for cytokines and exosome-based miRNAs All biosamples will be analyzed by mass spectrometry to assess impact of the environment on infant metabolism and physiology
Further follow-up experiments with the acquired samples are possible Specifically individual bacteria strains can be isolated and cultured in vitro and also tested alone or in combination in experimental animals
Bacterial sequencing by the methods described above will also inevitably identify maternal or infant DNA sequences since metagenomic shotgun sequencing cannot differentiate between bacterial and human DNA These human DNA sequences will not be analyzed within the scope of this project However these sequences might be the subject of future studies Study participants will therefore be asked for permission to analyze human DNA from mother and or child at the page for further analyses within the consent form An option to opt out for human DNA analysis will be provided and refusal will not lead to exclusion from the study
Any findings of clear relevance to the health of the participant ie mother or child will be reported to the participant in collaboration with their treating pediatrician Participants will need to inform the study team if they do not wish to be informed
For the primary objective and outcome endpoint of the study bacterial content of infant stool will be analyzed by
Mass spectrometry to assess intestinal content metabolome Techniques have been established in the laboratory of Prof U Sauer who already collaborated with the investigators group in previous studies
16S ribosomal ribonucleic acid rRNA sequencing for bacterial species composition as well as microbial diversity
Bacterial full genome metagenomics shotgun sequencing to identify bacterial genes present metabolic potential of the microbiota
Bacterial mRNA sequencing to assess transcription and a functional role of the microbiota metabolic activity of microbiota
Analysis of the intestinal virome and eukaryotic intestinal populations by appropriate sequencing or culturing techniques
Analysis of IgA antibodies in human milk and stool and the interaction of antibodies with intestinal bacteria
For the secondary endpoints identical analyses will be performed in skin swabs maternal milk maternal vaginal swabs and maternal stool Parameters for infant growth neurodevelopment immune maturation and potential occurrence of pathology will be assessed at every visit Maternal and infant nutrition hygiene socioeconomic status and clinical history will be assessed by questionnaires at every visit Milk samples will further be analyzed for their cellular contents by flow cytometry and single cell RNA-sequencing as well as for cytokines and exosome-based miRNAs All biosamples will be analyzed by mass spectrometry to assess impact of the environment on infant metabolism and physiology
Further follow-up experiments with the acquired samples are possible Specifically individual bacteria strains can be isolated and cultured in vitro and also tested alone or in combination in experimental animals
Bacterial sequencing by the methods described above will also inevitably identify maternal or infant DNA sequences since metagenomic shotgun sequencing cannot differentiate between bacterial and human DNA These human DNA sequences will not be analyzed within the scope of this project However these sequences might be the subject of future studies Study participants will therefore be asked for permission to analyze human DNA from mother and or child at the page for further analyses within the consent form An option to opt out for human DNA analysis will be provided and refusal will not lead to exclusion from the study
Any findings of clear relevance to the health of the participant ie mother or child will be reported to the participant in collaboration with their treating pediatrician Participants will need to inform the study team if they do not wish to be informed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 3962 | OTHER | Direktion Lehre und Forschung Insel Spital Bern | None |