Diet, HealthyNCT04976686
Low Carbohydrate Small Intestine Study
A study testing Diet modification in people with Diet, Healthy, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
The investigators will recruit probands with a ileo- or colostoma that are otherwise in good general health and analyse the stomal fluids for their microbiota composition. Sampling will be performed over a time span of 28 days, after 14 days probands will modify their base-line diet to a low carbohydrate diet. 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
- What is being tested?
- Diet modification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteSwitzerland
- Study dates
- 17 Nov 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
- Ileostomy or colostomy
- Good general health
- Written informed consent
Who cannot join
- Major metabolic diseases that prevent adherence to low carbohydrate diet
- Participation in other clinical trial interfering with study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Studying the Impact of a Low Carbohydrate Diet on the Small Intestinal Microbiota
The investigators will recruit probands with a ileo- or colostoma that are otherwise in good general health and analyse the stomal fluids for their microbiota composition. Sampling will be performed over a time span of 28 days, after 14 days probands will modify their base-line diet to a low carbohydrate diet.
Read the detailed description
Additionally to stoma fluids which will be analyzed for their microbiota composition the investigators will also collect skin samples to analyze for microbiota composition and urine to analyze for metabolite composition.
Low carbohydrate diet will allow for consumption of 80g complex carbohydrates per day, simple sugars will have to be avoided completely
- Conditions
- Diet, Healthy
- Being tested
- Diet modification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet modificationOther
Participants will reduce their carbohydrate consumption to 80g daily
| Study group | Role | What they receive |
|---|---|---|
| All study participants | Experimental | All participants will undergo sample collection during their regular diet and after modification of their diet to a low carbohydrate diet Receives: Other: Diet modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of microbiota profile by 16S sequencing before and after diet modification for significant differences
Sample content will be measured by 16S sequencing, ecological distances will be assessed by beta-diversity
Measured: 28 days
Secondary outcomes (5)
Relative changes of total metabolite abundance in urine
The whole metabolite composition will be assessed by an untargeted screen done with mass spectrometry
Measured: 28 days
Analysis of microbiota metabolic potential (microbiome DNA coding for enzymes) after shotgun sequencing
The total DNA content of the samples will be annotated for for known metabolic active enzymes to assess functionality
Measured: 28 days
Analysis of microbiota biomass
The samples will be analysed for the number of bacteria present in them
Measured: 28 days
Changes of further metagenomic microbiome composition (viral, eucaryotic DNA)
The DNA of the samples will be screened for parts belonging to viruses or eucaryotic cells
Measured: 28 days
Culturing of microbiota if appropriate (in vitro)
If of interest, culturing of specific bacterial strains will be attempted in vitro with the aim to recreate in vivo observations
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start17 Nov 2021
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Why it stopped: Halted after intervention group completed. Control group with only 3 participants
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.
- 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
- Not applicable
- Intervention model
- Sequential
- Model description
- First phase will be purely observational, second phase involves diet modification
- Masking
- None (open label)
- Enrolment
- 13 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
- NCT04976686
- Sponsor's protocol ID
- 2021-01262
- Status last verified
- Dec 2024
- First submitted
- 12 Jul 2021
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sharing of raw sequencing data as electronic supplement to publication (e.g. by entry on database)
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studying the Impact of a Low Carbohydrate Diet on the Small Intestinal Microbiota
- ClinicalTrials.gov ID
- NCT04976686
- Acronym / sponsor ID
- 2021-01262
- Conditions
- Diet, Healthy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Halted after intervention group completed. Control group with only 3 participants
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 17 Nov 2021 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 26 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.
The investigators will recruit probands with a ileo- or colostoma that are otherwise in good general health and analyse the stomal fluids for their microbiota composition. Sampling will be performed over a time span of 28 days, after 14 days probands will modify their base-line diet to a low carbohydrate diet.
Detailed description
Additionally to stoma fluids which will be analyzed for their microbiota composition the investigators will also collect skin samples to analyze for microbiota composition and urine to analyze for metabolite composition.
Low carbohydrate diet will allow for consumption of 80g complex carbohydrates per day, simple sugars will have to be avoided completely
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- First phase will be purely observational, second phase involves diet modification
| Arm | Type | Receives |
|---|---|---|
| All study participants | Experimental | Other: Diet modificationAll participants will undergo sample collection during their regular diet and after modification of their diet to a low carbohydrate diet |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ileostomy or colostomy
- Good general health
- Written informed consent
Key exclusion criteria (2 listed)
- Major metabolic diseases that prevent adherence to low carbohydrate diet
- 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 |
|---|---|---|
| Diet modificationParticipants will reduce their carbohydrate consumption to 80g daily | Other | All study participants |
Primary outcome
Assessment of microbiota profile by 16S sequencing before and after diet modification for significant differences
Time frame: 28 days
Sample content will be measured by 16S sequencing, ecological distances will be assessed by beta-diversity
5 secondary outcomes
Relative changes of total metabolite abundance in urine
Time frame: 28 days
Analysis of microbiota metabolic potential (microbiome DNA coding for enzymes) after shotgun sequencing
Time frame: 28 days
Analysis of microbiota biomass
Time frame: 28 days
Changes of further metagenomic microbiome composition (viral, eucaryotic DNA)
Time frame: 28 days
Culturing of microbiota if appropriate (in vitro)
Time frame: 28 days
Results and safety
The study was stopped early (reason given: Halted after intervention group completed. Control group with only 3 participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: Yes. Sharing of raw sequencing data as electronic supplement to publication (e.g. by entry on database)
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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 Diet modification in people with Diet, Healthy, 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 9 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: Halted after intervention group completed. Control group with only 3 participants). 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?
Assessment of microbiota profile by 16S sequencing before and after diet modification for significant differences (time frame: 28 days). 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 9 Dec 2024; AzTrials last refreshed its copy on 31 Oct 2026.