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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04978077
Other study ID # 2021-01108
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 16, 2021
Est. completion date July 2024

Study information

Verified date November 2023
Source Insel Gruppe AG, University Hospital Bern
Contact Benjamin Misselwitz, Prof. Dr. med.
Phone 31 632 59 00
Email benjamin.misselwitz@dbmr.unibe.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 270
Est. completion date July 2024
Est. primary completion date July 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Intervention

Other:
Test meal (high fat = Nutricia Calogen®, or high carbohydrate = Nutricia preOp®)
After a night fast participants will drink the test meal

Locations

Country Name City State
Switzerland Inselspital Bern

Sponsors (1)

Lead Sponsor Collaborator
Insel Gruppe AG, University Hospital Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Identification of stimulating and inhibiting metabolite and bacteria interactions Correlation of results of secondary outcome measures to find interactions 8 hours
Primary Reproduction of metabolite-bacteria interactions in vitro culture By culturing of bacteria with possible interactions together in vitro 2 weeks
Secondary Analysis of bacteria species composition by 16S rRNA sequencing of sample content 8 hours
Secondary 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 2 weeks
Secondary Metabolite composition in intestinal fluids by untargeted mass spectrometry 8 hours
Secondary Metabolite composition in blood by untargeted mass spectrometry 8 hours
Secondary Metabolite composition in urine by untargeted mass spectrometry 8 hours
Secondary Metabolite composition in intestinal fluids, blood and urine by untargeted mass spectrometry 8 hours
Secondary Analyze eucaryotic and viral microbiome composition by shotgun sequencing of sample content 8 hours
Secondary Analysis of microbiota metabolic potential by shotgun sequencing of sample content 8 hours
Secondary Analysis of microbiota metabolic activity by sequencing of transcriptome of sample content 8 hours
Secondary Analysis of microbiota biomass by measuring absolute bacteria counts by flow cytometry of 16S spiking 8 hours
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