Networks of Bacterium-Metabolite Interactions in the Small Intestine

Not Applicable

Terminated

• Conditions: Microbial Colonization; Diet, Healthy
• Interventions: Other: Test meal (high fat = Nutricia Calogen®, or high carbohydrate = Nutricia preOp®)

• Registration Number: NCT04978077
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

Study Timeline

• Study First Submitted: 2021-07-12
• Study First Submitted QC: 2021-07-15
• Study First Posted: 2021-07-27
• Study Start: 2021-12-16
• Primary Completion: 2024-11-30
• Study Completion: 2024-11-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High fat test meal first, high carbohydrate test meal second	Test meal (high fat = Nutricia Calogen®, or high carbohydrate = Nutricia preOp®)	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	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Metabolite composition in blood	8 hours	by untargeted mass spectrometry
Metabolite composition in urine	8 hours	by untargeted mass spectrometry
Metabolite composition in intestinal fluids, blood and urine	8 hours	by untargeted mass spectrometry
Analysis of bacteria species composition	8 hours	by 16S rRNA sequencing of sample content
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
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
Analysis of microbiota metabolic activity	8 hours	by sequencing of transcriptome of sample content
Metabolite composition in intestinal fluids	8 hours	by untargeted mass spectrometry
Analysis of microbiota biomass	8 hours	by measuring absolute bacteria counts by flow cytometry of 16S spiking

Trial Locations

Locations (1)

Inselspital; 🇨🇭 Bern, Switzerland