An interventional study of Diet modification in Diet, Healthy, sponsored by Insel Gruppe AG, University Hospital Bern. Terminated at 1 site in Switzerland. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-09.
Sponsored by Insel Gruppe AG, University Hospital Bern · Not applicable, Interventional, and Basic science
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.
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
Insel Gruppe AG, University Hospital Bern is the lead sponsor of 724 studies on the registry; 177 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All participants will undergo sample collection during their regular diet and after modification of their diet to a low carbohydrate diet
Other: Diet modification
Participants will reduce their carbohydrate consumption to 80g daily
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
Time frame: 28 days
Relative changes of total metabolite abundance in urine
The whole metabolite composition will be assessed by an untargeted screen done with mass spectrometry
Time frame: 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
Time frame: 28 days
Analysis of microbiota biomass
The samples will be analysed for the number of bacteria present in them
Time frame: 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
Time frame: 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
Time frame: 28 days
Plan to share: Yes — Sharing of raw sequencing data as electronic supplement to publication (e.g. by entry on database)
No publications or documents are linked to this record.
This study is terminated, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Insel Gruppe AG, University Hospital Bern