Low Carbohydrate Small Intestine Study
December 4, 2024 updated by: Insel Gruppe AG, University Hospital Bern
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
13
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bern, Switzerland, 3010
- Inselspital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Ileostomy or colostomy
- Good general health
- Written informed consent
Exclusion Criteria:
- Major metabolic diseases that prevent adherence to low carbohydrate diet
- Participation in other clinical trial interfering with study protocol
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: All study participants
All participants will undergo sample collection during their regular diet and after modification of their diet to a low carbohydrate diet
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Participants will reduce their carbohydrate consumption to 80g daily
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of microbiota profile by 16S sequencing before and after diet modification for significant differences
Time Frame: 28 days
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Sample content will be measured by 16S sequencing, ecological distances will be assessed by beta-diversity
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28 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Relative changes of total metabolite abundance in urine
Time Frame: 28 days
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The whole metabolite composition will be assessed by an untargeted screen done with mass spectrometry
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28 days
|
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Analysis of microbiota metabolic potential (microbiome DNA coding for enzymes) after shotgun sequencing
Time Frame: 28 days
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The total DNA content of the samples will be annotated for for known metabolic active enzymes to assess functionality
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28 days
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Analysis of microbiota biomass
Time Frame: 28 days
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The samples will be analysed for the number of bacteria present in them
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28 days
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Changes of further metagenomic microbiome composition (viral, eucaryotic DNA)
Time Frame: 28 days
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The DNA of the samples will be screened for parts belonging to viruses or eucaryotic cells
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28 days
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Culturing of microbiota if appropriate (in vitro)
Time Frame: 28 days
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If of interest, culturing of specific bacterial strains will be attempted in vitro with the aim to recreate in vivo observations
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28 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Benjamin Misselwitz, Prof. Dr. med., University Clinic for Visceral Surgery and Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 17, 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 26, 2021
Study Record Updates
Last Update Posted (Estimated)
December 9, 2024
Last Update Submitted That Met QC Criteria
December 4, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 2021-01262
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Sharing of raw sequencing data as electronic supplement to publication (e.g. by entry on database)
IPD Sharing Time Frame
upon publication, unlimited
IPD Sharing Access Criteria
Open 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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.