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Low Carbohydrate Small Intestine Study

NCT ID: NCT04976686

Last Updated: 2024-12-09

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

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-17

Study Completion Date

2024-11-30

Brief Summary

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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

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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

Conditions

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Diet, Healthy

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

First phase will be purely observational, second phase involves diet modification
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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All study participants

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

Group Type EXPERIMENTAL

Diet modification

Intervention Type OTHER

Participants will reduce their carbohydrate consumption to 80g daily

Interventions

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Diet modification

Participants will reduce their carbohydrate consumption to 80g daily

Intervention Type OTHER

Eligibility Criteria

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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
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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2021-01262

Identifier Type: -

Identifier Source: org_study_id