An interventional study of Test meal (high fat = Nutricia Calogen®, or high carbohydrate = Nutricia preOp®) in Diet, Healthy and Microbial Colonization, sponsored by Insel Gruppe AG, University Hospital Bern. Terminated at 1 site in Switzerland. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-11.
Sponsored by Insel Gruppe AG, University Hospital Bern · Not applicable, Interventional, and Basic science
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.
4,448 studies on the registry are indexed under Communicable Diseases; 514 are open to participants now.
This study's enrollment of 120 is close to the median of 121 across 2,712 interventional studies indexed under Communicable Diseases.
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Exclusion Criteria:
Consumption of a high fat challenge first, consumption of a high carbohydrate challenge after two weeks wash out
Other: Test meal (high fat = Nutricia Calogen®, or high carbohydrate = Nutricia preOp®)
Consumption of a high carbohydrate challenge first, consumption of a high fit challenge after two weeks wash out
Other: Test meal (high fat = Nutricia Calogen®, or high carbohydrate = Nutricia preOp®)
After a night fast participants will drink the test meal
Identification of stimulating and inhibiting metabolite and bacteria interactions
Correlation of results of secondary outcome measures to find interactions
Time frame: 8 hours
Reproduction of metabolite-bacteria interactions in vitro culture
By culturing of bacteria with possible interactions together in vitro
Time frame: 2 weeks
Analysis of bacteria species composition
by 16S rRNA sequencing of sample content
Time frame: 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
Time frame: 2 weeks
Metabolite composition in intestinal fluids
by untargeted mass spectrometry
Time frame: 8 hours
Metabolite composition in blood
by untargeted mass spectrometry
Time frame: 8 hours
Metabolite composition in urine
by untargeted mass spectrometry
Time frame: 8 hours
Metabolite composition in intestinal fluids, blood and urine
by untargeted mass spectrometry
Time frame: 8 hours
Analyze eucaryotic and viral microbiome composition
by shotgun sequencing of sample content
Time frame: 8 hours
Analysis of microbiota metabolic potential
by shotgun sequencing of sample content
Time frame: 8 hours
Analysis of microbiota metabolic activity
by sequencing of transcriptome of sample content
Time frame: 8 hours
Analysis of microbiota biomass
by measuring absolute bacteria counts by flow cytometry of 16S spiking
Time frame: 8 hours
Plan to share: Yes — Sequencing data will be shared in a public repository
Time frame: upon publication of study results open ended
Access criteria: public access
No publications or documents are linked to this record.
Ran from Dec 2021 to primary completion in Nov 2024, 35 months.
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This study is terminated, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Insel Gruppe AG, University Hospital Bern →