Diet, Healthy, Microbial Colonization
Conditions
Brief summary
Probands with an Ileo- or Colostomy are assigned to consume a test meal which is either high in fat or high in carbohydrates. After the test meal samples from the stoma, urine, blood and skin are retrieved. These will be subjected to large scale analyses of microbiota and metabolite content. To get a better comparability test subjects will consume a standardized liquid diet three days before the study day.
Detailed description
Between both study days a two week wash out phase will be done. During the study day sampling will be done at set time points until 8 hours after the consumption of the test meal.
Interventions
OTHERTest meal (high fat = Nutricia Calogen®, or high carbohydrate = Nutricia preOp®)
After a night fast participants will drink the test meal
Sponsors
Insel Gruppe AG, University Hospital Bern
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Written informed consent * General good health * Ileostomy or colostomy
Exclusion criteria
* Hematologic disorders with contraindication of blood draw * Participation in other clinical trial interfering with study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identification of stimulating and inhibiting metabolite and bacteria interactions | 8 hours | Correlation of results of secondary outcome measures to find interactions |
| Reproduction of metabolite-bacteria interactions in vitro culture | 2 weeks | By culturing of bacteria with possible interactions together in vitro |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Metabolite composition in intestinal fluids | 8 hours | by untargeted mass spectrometry |
| Metabolite composition in blood | 8 hours | by untargeted mass spectrometry |
| Analysis of bacteria species composition | 8 hours | by 16S rRNA sequencing of sample content |
| Metabolite composition in urine | 8 hours | by untargeted mass spectrometry |
| Cultivation of bacterial strains in various conditions including ileal fluids | 2 weeks | Cultivation of native species found in samples, as well as dedicated E. coli with recording capacity for transcriptional changes |
| Metabolite composition in intestinal fluids, blood and urine | 8 hours | by untargeted mass spectrometry |
| Analyze eucaryotic and viral microbiome composition | 8 hours | by shotgun sequencing of sample content |
| Analysis of microbiota metabolic potential | 8 hours | by shotgun sequencing of sample content |
| Analysis of microbiota metabolic activity | 8 hours | by sequencing of transcriptome of sample content |
| Analysis of microbiota biomass | 8 hours | by measuring absolute bacteria counts by flow cytometry of 16S spiking |
Countries
Switzerland
Outcome results
None listed