Low Carbohydrate Small Intestine Study

Insel Gruppe AG, University Hospital Bern

Status: Terminated

Conditions: Diet, Healthy

Treatments: Other: Diet modification

Study type: Interventional

Funder types: Other

Identifiers

NCT04976686

2021-01262

Details and patient eligibility

About

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.

Full 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

Enrollment: 13 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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13 participants in 1 patient group

All study participants

Experimental group

Description:

All participants will undergo sample collection during their regular diet and after modification of their diet to a low carbohydrate diet

Treatment:

Other: Diet modification