Skip to content

Low Carbohydrate Small Intestine Study

Studying the Impact of a Low Carbohydrate Diet on the Small Intestinal Microbiota

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04976686
Enrollment
13
Registered
2021-07-26
Start date
2021-11-17
Completion date
2024-11-30
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diet, Healthy

Brief 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.

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

Interventions

OTHERDiet modification

Participants will reduce their carbohydrate consumption to 80g daily

Sponsors

Insel Gruppe AG, University Hospital Bern
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

First phase will be purely observational, second phase involves diet modification

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Assessment of microbiota profile by 16S sequencing before and after diet modification for significant differences28 daysSample content will be measured by 16S sequencing, ecological distances will be assessed by beta-diversity

Secondary

MeasureTime frameDescription
Relative changes of total metabolite abundance in urine28 daysThe whole metabolite composition will be assessed by an untargeted screen done with mass spectrometry
Analysis of microbiota metabolic potential (microbiome DNA coding for enzymes) after shotgun sequencing28 daysThe total DNA content of the samples will be annotated for for known metabolic active enzymes to assess functionality
Analysis of microbiota biomass28 daysThe samples will be analysed for the number of bacteria present in them
Changes of further metagenomic microbiome composition (viral, eucaryotic DNA)28 daysThe DNA of the samples will be screened for parts belonging to viruses or eucaryotic cells
Culturing of microbiota if appropriate (in vitro)28 daysIf of interest, culturing of specific bacterial strains will be attempted in vitro with the aim to recreate in vivo observations

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026