Networks of Bacterium-Metabolite Interactions in the Small Intestine

Insel Gruppe AG, University Hospital Bern120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

120

Conditions

Diet, Healthy Microbial Colonization

Interventions

Test meal (high fat = Nutricia Calogen®, or high carbohydrate = Nutricia preOp®)OTHER

After a night fast participants will drink the test meal

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Inselspital

Bern, Switzerland

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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