Development of the oropharyngeal microbiome
Conditions
Interventions
Group 1: Newborns fed with colostrum.
Group 2: Newborns who are formula-fed.
Sponsors
Institut für Wirkstoffentwicklung
Eligibility
Sex/Gender
All
Age
No minimum to 1 Days
Inclusion criteria
Inclusion criteria: - Existing oropharyngeal feeding - Written declaration of consent from the legal guardians after a detailed, personal discussion and inspection of the parental information sheet. - Newborns born after the 30th week of pregnancy - Children who do not receive colostrum but only formula food (control group)
Exclusion criteria
Exclusion criteria: - Newborns who receive colostrum exclusively via a stomach tube. - Colostrum administration before the first sample collection - Newborns who receive donated (pooled) breast milk - Severe malformations of the thorax, abdomen or internal organs - Chromosomal aberrations - sepsis and/or relevantly impaired general condition.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Presence of different taxa of the oropharyngeal microbiome, relative quantification of 16S rRNA by Illumina sequencing - Up/downregulation of bacterial target genes and proteins, relative quantification of transcript levels comparing day 0 to day 1 and 2 by Illumina sequencing. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Dynamics of the oropharyngeal microbiome over time, investigation using bioinformatic analyses: time series analysis (e.g. clustering, PCA, heat maps) Alpha and beta diversity analyses to visualize microbial diversity over time, differential abundance analyses (e.g. with DESeq2 or ANCOM) to detect significant changes in individual taxa or gene groups | — |
Countries
Germany
Contacts
Public ContactMaria Kulosa
Institut für Wirkstoffentwicklung
Outcome results
None listed