Trajectory of Microbiota Maturation in Healthy Bern Infants - a Network Approach
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- STATUS
- Recruiting
-
- End date
- Mar 3, 2035
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- participants needed
- 120
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- sponsor
- University Hospital Inselspital, Berne
Summary
Background: Intestinal
Aims: The investigators aim for a deep understanding of the maturation of the healthy infant
intestinal
Methods: The investigators will recruit 120 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
Species composition and diversity will be assessed by 16S
Expected results: The investigators expect an increase in complexity and metabolic potential
and activity with age.
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 themicrobiota ). - Bacterial mRNA
sequencing to assess transcription and a functional role of themicrobiota (metabolic activity ofmicrobiota ). - Analysis of the intestinal virome and eukaryotic intestinal populations by appropriate
sequencing or culturing techniques. - Analysis of
immunoglobulin A (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
Further follow-up experiments with the acquired samples are possible. Specifically,
individual bacteria
Bacterial
Any findings of clear relevance to the health of the participant (i.e. 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.
Details
Condition |
Infant Nutrition Disorders, Microbial Colonization, Maturation of the Healthy Infant Intestinal |
---|---|
Age | 18years - 45years |
Clinical Study Identifier | NCT04447742 |
Sponsor | University Hospital Inselspital, Berne |
Last Modified on | 19 February 2024 |
How to participate?
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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