Networks of Bacterium-Metabolite Interactions in the Small Intestine

Insel Gruppe AG, University Hospital Bern

Status: Terminated

Conditions: Microbial Colonization; Diet, Healthy

Treatments: Other: Test meal (high fat = Nutricia Calogen®, or high carbohydrate = Nutricia preOp®)

Study type: Interventional

Funder types: Other

Identifiers

NCT04978077

2021-01108

Details and patient eligibility

About

Probands with an Ileo- or Colostomy are assigned to consume a test meal which is either high in fat or high in carbohydrates. After the test meal samples from the stoma, urine, blood and skin are retrieved. These will be subjected to large scale analyses of microbiota and metabolite content. To get a better comparability test subjects will consume a standardized liquid diet three days before the study day.

Full description

Between both study days a two week wash out phase will be done. During the study day sampling will be done at set time points until 8 hours after the consumption of the test meal.

Enrollment: 120 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Written informed consent
• General good health
• Ileostomy or colostomy

Exclusion criteria

• Hematologic disorders with contraindication of blood draw
• Participation in other clinical trial interfering with study protocol

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

High fat test meal first, high carbohydrate test meal second

Experimental group

Description:

Consumption of a high fat challenge first, consumption of a high carbohydrate challenge after two weeks wash out

Treatment:

Other: Test meal (high fat = Nutricia Calogen®, or high carbohydrate = Nutricia preOp®)

High carbohydrate test meal first, high fat test meal second

Experimental group

Description:

Consumption of a high carbohydrate challenge first, consumption of a high fit challenge after two weeks wash out

Treatment:

Other: Test meal (high fat = Nutricia Calogen®, or high carbohydrate = Nutricia preOp®)