Low Carbohydrate Small Intestine Study

Diet, Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04976686
• Other study ID #: 2021-01262
• Status: Recruiting
• Phase: N/A
• Start date: November 17, 2021
• Est. completion date: March 2024

Study information

• Verified date: November 2023
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: Benjamin Misselwitz, Prof. Dr. med.
• Phone: 31 632 59 00
• Email: benjamin.misselwitz[@]dbmr.unibe.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diet, Healthy

Intervention

Other:
• Diet modification
Participants will reduce their carbohydrate consumption to 80g daily

Locations

Country	Name	City	State
Switzerland	Inselspital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Insel Gruppe AG, University Hospital Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	28 days
Secondary	Relative changes of total metabolite abundance in urine	The whole metabolite composition will be assessed by an untargeted screen done with mass spectrometry	28 days
Secondary	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	28 days
Secondary	Analysis of microbiota biomass	The samples will be analysed for the number of bacteria present in them	28 days
Secondary	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	28 days
Secondary	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	28 days