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Networks of Bacterium-Metabolite Interactions in the Small Intestine

NCT ID: NCT04978077

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-16

Study Completion Date

2024-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diet, Healthy Microbial Colonization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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High fat test meal first, high carbohydrate test meal second

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

Group Type EXPERIMENTAL

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

Intervention Type OTHER

After a night fast participants will drink the test meal

High carbohydrate test meal first, high fat test meal second

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

Group Type EXPERIMENTAL

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

Intervention Type OTHER

After a night fast participants will drink the test meal

Interventions

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

After a night fast participants will drink the test meal

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Benjamin Misselwitz, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University Clinic for Visceral Surgery and Medicine

Locations

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Inselspital

Bern, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2021-01108

Identifier Type: -

Identifier Source: org_study_id