Diet, HealthyNCT04978077
Networks of Bacterium-Metabolite Interactions in the Small Intestine
A study testing Test meal (high fat = Nutricia Calogen®, or high carbohydrate = Nutricia preOp®) in people with Diet, Healthy and Microbial Colonization, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet, Healthy, Microbial Colonization
- What is being tested?
- Test meal (high fat = Nutricia Calogen®, or high carbohydrate = Nutricia preOp®)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSwitzerland
- Study dates
- 16 Dec 2021to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent
- General good health
- Ileostomy or colostomy
Who cannot join
- Hematologic disorders with contraindication of blood draw
- Participation in other clinical trial interfering with study protocol
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Diet, Healthy, Microbial Colonization
- Being tested
- Test meal (high fat = Nutricia Calogen®, or high carbohydrate = Nutricia preOp®)
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test meal (high fat = Nutricia Calogen®, or high carbohydrate = Nutricia preOp®)Other
After a night fast participants will drink the test meal
| Study group | Role | What they receive |
|---|---|---|
| High fat test meal first, high carbohydrate test meal second | Experimental | Consumption of a high fat challenge first, consumption of a high carbohydrate challenge after two weeks wash out Receives: Other: Test meal (high fat = Nutricia Calogen®, or high carbohydrate = Nutricia preOp®) |
| High carbohydrate test meal first, high fat test meal second | Experimental | Consumption of a high carbohydrate challenge first, consumption of a high fit challenge after two weeks wash out Receives: Other: Test meal (high fat = Nutricia Calogen®, or high carbohydrate = Nutricia preOp®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of stimulating and inhibiting metabolite and bacteria interactions
Correlation of results of secondary outcome measures to find interactions
Measured: 8 hours
Reproduction of metabolite-bacteria interactions in vitro culture
By culturing of bacteria with possible interactions together in vitro
Measured: 2 weeks
Secondary outcomes (10)
Analysis of bacteria species composition
by 16S rRNA sequencing of sample content
Measured: 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
Measured: 2 weeks
Metabolite composition in intestinal fluids
by untargeted mass spectrometry
Measured: 8 hours
Metabolite composition in blood
by untargeted mass spectrometry
Measured: 8 hours
Metabolite composition in urine
by untargeted mass spectrometry
Measured: 8 hours
Metabolite composition in intestinal fluids, blood and urine
by untargeted mass spectrometry
Measured: 8 hours
Analyze eucaryotic and viral microbiome composition
by shotgun sequencing of sample content
Measured: 8 hours
Analysis of microbiota metabolic potential
by shotgun sequencing of sample content
Measured: 8 hours
Analysis of microbiota metabolic activity
by sequencing of transcriptome of sample content
Measured: 8 hours
Analysis of microbiota biomass
by measuring absolute bacteria counts by flow cytometry of 16S spiking
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start16 Dec 2021
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Why it stopped: The recruitment of the specific study population consisting of stoma patients proved escpecially difficult, so the recruitment was halted before the anticipated target number
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet, HealthyStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Misselwitz, Prof. Dr. med., Principal investigator, University Clinic for Visceral Surgery and Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04978077
- Sponsor's protocol ID
- 2021-01108
- Status last verified
- Dec 2024
- First submitted
- 12 Jul 2021
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sequencing data will be shared in a public repository
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Networks of Bacterium-Metabolite Interactions in the Small Intestine
- ClinicalTrials.gov ID
- NCT04978077
- Acronym / sponsor ID
- 2021-01108
- Conditions
- Diet, Healthy, Microbial Colonization
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The recruitment of the specific study population consisting of stoma patients proved escpecially difficult, so the recruitment was halted before the anticipated target number
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 16 Dec 2021 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 27 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High fat test meal first, high carbohydrate test meal second | Experimental | Other: 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 | Experimental | Other: 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent
- General good health
- Ileostomy or colostomy
Key exclusion criteria (2 listed)
- Hematologic disorders with contraindication of blood draw
- Participation in other clinical trial interfering with study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test meal (high fat = Nutricia Calogen®, or high carbohydrate = Nutricia preOp®)After a night fast participants will drink the test meal | Other | High carbohydrate test meal first, high fat test meal second, High fat test meal first, high carbohydrate test meal second |
Primary outcome
Identification of stimulating and inhibiting metabolite and bacteria interactions
Time frame: 8 hours
Correlation of results of secondary outcome measures to find interactions
Reproduction of metabolite-bacteria interactions in vitro culture
Time frame: 2 weeks
By culturing of bacteria with possible interactions together in vitro
10 secondary outcomes
Analysis of bacteria species composition
Time frame: 8 hours
Cultivation of bacterial strains in various conditions including ileal fluids
Time frame: 2 weeks
Metabolite composition in intestinal fluids
Time frame: 8 hours
Metabolite composition in blood
Time frame: 8 hours
Metabolite composition in urine
Time frame: 8 hours
Metabolite composition in intestinal fluids, blood and urine
Time frame: 8 hours
Analyze eucaryotic and viral microbiome composition
Time frame: 8 hours
Analysis of microbiota metabolic potential
Time frame: 8 hours
Analysis of microbiota metabolic activity
Time frame: 8 hours
Analysis of microbiota biomass
Time frame: 8 hours
Results and safety
The study was stopped early (reason given: The recruitment of the specific study population consisting of stoma patients proved escpecially difficult, so the recruitment was halted before the anticipated target number). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Individual participant dataSharing planned: Yes. Sequencing data will be shared in a public repository
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Misselwitz, Prof. Dr. med. principal investigator
University Clinic for Visceral Surgery and Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test meal (high fat = Nutricia Calogen®, or high carbohydrate = Nutricia preOp®) in people with Diet, Healthy and Microbial Colonization, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The recruitment of the specific study population consisting of stoma patients proved escpecially difficult, so the recruitment was halted before the anticipated target number). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of stimulating and inhibiting metabolite and bacteria interactions (time frame: 8 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.