Low Carbohydrate Small Intestine Study

Not Applicable

Terminated

• Conditions: Diet, Healthy
• Interventions: Other: Diet modification

• Registration Number: NCT04976686
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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

Study Timeline

• Study First Submitted: 2021-07-12
• Study First Submitted QC: 2021-07-15
• Study First Posted: 2021-07-26
• Study Start: 2021-11-17
• Primary Completion: 2024-11-30
• Study Completion: 2024-11-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
All study participants	Diet modification	All participants will undergo sample collection during their regular diet and after modification of their diet to a low carbohydrate diet

Primary Outcome Measures

Name	Time	Method
Assessment of microbiota profile by 16S sequencing before and after diet modification for significant differences	28 days	Sample content will be measured by 16S sequencing, ecological distances will be assessed by beta-diversity

Secondary Outcome Measures

Name	Time	Method
Changes of further metagenomic microbiome composition (viral, eucaryotic DNA)	28 days	The DNA of the samples will be screened for parts belonging to viruses or eucaryotic cells
Culturing of microbiota if appropriate (in vitro)	28 days	If of interest, culturing of specific bacterial strains will be attempted in vitro with the aim to recreate in vivo observations
Analysis of microbiota biomass	28 days	The samples will be analysed for the number of bacteria present in them
Relative changes of total metabolite abundance in urine	28 days	The 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 sequencing	28 days	The total DNA content of the samples will be annotated for for known metabolic active enzymes to assess functionality

Trial Locations

Locations (1)

Inselspital; 🇨🇭 Bern, Switzerland