Back to resultsNetworks of Bacterium-Metabolite Interactions in the Small Intestine
Primary Purpose
Diet, Healthy, Microbial Colonization
Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Test meal (high fat = Nutricia Calogen®, or high carbohydrate = Nutricia preOp®)
Sponsored by
About this trial
This is an interventional basic science trial for Diet, Healthy
Eligibility Criteria
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
Sites / Locations
- InselspitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
High fat test meal first, high carbohydrate test meal second
High carbohydrate test meal first, high fat test meal second
Arm Description
Consumption of a high fat challenge first, consumption of a high carbohydrate challenge after two weeks wash out
Consumption of a high carbohydrate challenge first, consumption of a high fit challenge after two weeks wash out
Outcomes
Primary Outcome Measures
Identification of stimulating and inhibiting metabolite and bacteria interactions
Correlation of results of secondary outcome measures to find interactions
Reproduction of metabolite-bacteria interactions in vitro culture
By culturing of bacteria with possible interactions together in vitro
Secondary Outcome Measures
Analysis of bacteria species composition
by 16S rRNA sequencing of sample content
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
Metabolite composition in intestinal fluids
by untargeted mass spectrometry
Metabolite composition in blood
by untargeted mass spectrometry
Metabolite composition in urine
by untargeted mass spectrometry
Metabolite composition in intestinal fluids, blood and urine
by untargeted mass spectrometry
Analyze eucaryotic and viral microbiome composition
by shotgun sequencing of sample content
Analysis of microbiota metabolic potential
by shotgun sequencing of sample content
Analysis of microbiota metabolic activity
by sequencing of transcriptome of sample content
Analysis of microbiota biomass
by measuring absolute bacteria counts by flow cytometry of 16S spiking
Full Information
NCT ID
NCT04978077
First Posted
July 12, 2021
Last Updated
May 24, 2022
Sponsor
Insel Gruppe AG, University Hospital Bern
1. Study Identification
Unique Protocol Identification Number
NCT04978077
Brief Title
Networks of Bacterium-Metabolite Interactions in the Small Intestine
Official Title
Networks of Bacterium-Metabolite Interactions in the Small Intestine
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 16, 2021 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diet, Healthy, Microbial Colonization
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
270 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High fat test meal first, high carbohydrate test meal second
Arm Type
Experimental
Arm Description
Consumption of a high fat challenge first, consumption of a high carbohydrate challenge after two weeks wash out
Arm Title
High carbohydrate test meal first, high fat test meal second
Arm Type
Experimental
Arm Description
Consumption of a high carbohydrate challenge first, consumption of a high fit challenge after two weeks wash out
Intervention Type
Other
Intervention Name(s)
Test meal (high fat = Nutricia Calogen®, or high carbohydrate = Nutricia preOp®)
Intervention Description
After a night fast participants will drink the test meal
Primary Outcome Measure Information:
Title
Identification of stimulating and inhibiting metabolite and bacteria interactions
Description
Correlation of results of secondary outcome measures to find interactions
Time Frame
8 hours
Title
Reproduction of metabolite-bacteria interactions in vitro culture
Description
By culturing of bacteria with possible interactions together in vitro
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Analysis of bacteria species composition
Description
by 16S rRNA sequencing of sample content
Time Frame
8 hours
Title
Cultivation of bacterial strains in various conditions including ileal fluids
Description
Cultivation of native species found in samples, as well as dedicated E. coli with recording capacity for transcriptional changes
Time Frame
2 weeks
Title
Metabolite composition in intestinal fluids
Description
by untargeted mass spectrometry
Time Frame
8 hours
Title
Metabolite composition in blood
Description
by untargeted mass spectrometry
Time Frame
8 hours
Title
Metabolite composition in urine
Description
by untargeted mass spectrometry
Time Frame
8 hours
Title
Metabolite composition in intestinal fluids, blood and urine
Description
by untargeted mass spectrometry
Time Frame
8 hours
Title
Analyze eucaryotic and viral microbiome composition
Description
by shotgun sequencing of sample content
Time Frame
8 hours
Title
Analysis of microbiota metabolic potential
Description
by shotgun sequencing of sample content
Time Frame
8 hours
Title
Analysis of microbiota metabolic activity
Description
by sequencing of transcriptome of sample content
Time Frame
8 hours
Title
Analysis of microbiota biomass
Description
by measuring absolute bacteria counts by flow cytometry of 16S spiking
Time Frame
8 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benjamin Misselwitz, Prof. Dr. med.
Phone
31 632 59 00
Ext
+41
Email
benjamin.misselwitz@dbmr.unibe.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Misselwitz, Prof. Dr. med.
Organizational Affiliation
University Clinic for Visceral Surgery and Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inselspital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin Misselwitz, Prof. Dr. med.
First Name & Middle Initial & Last Name & Degree
Benjamin Misselwitz, Prof. Dr. med.
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Networks of Bacterium-Metabolite Interactions in the Small Intestine
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