Networks of Bacterium-Metabolite Interactions in the Small Intestine

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.

Study Overview

• Status: Terminated
• Conditions: Microbial Colonization; Diet, Healthy
• Intervention / Treatment: Other: Test meal (high fat = Nutricia Calogen®, or high carbohydrate = Nutricia preOp®)

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High fat test meal first, high carbohydrate test meal second; 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®); After a night fast participants will drink the test meal
Experimental: High carbohydrate test meal first, high fat test meal second; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Investigators: Principal Investigator: Benjamin Misselwitz, Prof. Dr. med., University Clinic for Visceral Surgery and Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2021
• Primary Completion (Actual): November 30, 2024
• Study Completion (Actual): November 30, 2024

Study Registration Dates

• First Submitted: July 12, 2021
• First Submitted That Met QC Criteria: July 15, 2021
• First Posted (Actual): July 27, 2021

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: 2021-01108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Sequencing data will be shared in a public repository
• IPD Sharing Time Frame: upon publication of study results open ended
• IPD Sharing Access Criteria: public access

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No