Not provided
Not provided
Not provided
Not provided
Not provided
The recruitment of the specific study population consisting of stoma patients proved escpecially difficult, so the recruitment was halted before the anticipated target number
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High fat test meal first, high carbohydrate test meal second | Experimental | Consumption of a high fat challenge first, consumption of a high carbohydrate challenge after two weeks wash out |
|
| High carbohydrate test meal first, high fat test meal second | Experimental | Consumption of a high carbohydrate challenge first, consumption of a high fit challenge after two weeks wash out |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test meal (high fat = Nutricia Calogen®, or high carbohydrate = Nutricia preOp®) | Other | After a night fast participants will drink the test meal |
|
| Measure | Description | Time Frame |
|---|---|---|
| Identification of stimulating and inhibiting metabolite and bacteria interactions | Correlation of results of secondary outcome measures to find interactions | 8 hours |
| Reproduction of metabolite-bacteria interactions in vitro culture | By culturing of bacteria with possible interactions together in vitro | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of bacteria species composition | by 16S rRNA sequencing of sample content | 8 hours |
| Cultivation of bacterial strains in various conditions including ileal fluids | Cultivation of native species found in samples, as well as dedicated E. coli with recording capacity for transcriptional changes |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Benjamin Misselwitz, Prof. Dr. med. | University Clinic for Visceral Surgery and Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inselspital | Bern | 3010 | Switzerland |
Sequencing data will be shared in a public repository
Not provided
upon publication of study results open ended
public access
Not provided
Not provided
| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 2 weeks |
| Metabolite composition in intestinal fluids | by untargeted mass spectrometry | 8 hours |
| Metabolite composition in blood | by untargeted mass spectrometry | 8 hours |
| Metabolite composition in urine | by untargeted mass spectrometry | 8 hours |
| Metabolite composition in intestinal fluids, blood and urine | by untargeted mass spectrometry | 8 hours |
| Analyze eucaryotic and viral microbiome composition | by shotgun sequencing of sample content | 8 hours |
| Analysis of microbiota metabolic potential | by shotgun sequencing of sample content | 8 hours |
| Analysis of microbiota metabolic activity | by sequencing of transcriptome of sample content | 8 hours |
| Analysis of microbiota biomass | by measuring absolute bacteria counts by flow cytometry of 16S spiking | 8 hours |