Networks of Bacterium-Metabolite Interactions in the Small Intestine

Microbial Colonization Clinical Trial

Official title:

Networks of Bacterium-Metabolite Interactions in the Small Intestine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04978077
• Other study ID #: 2021-01108
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Communicable Diseases
• Diet, Healthy
• Infections
• Microbial Colonization

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