Biomarkers for Intestinal Permeability

NCT ID: NCT04667208

Last Updated: 2021-01-26

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

COMPLETED

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-01-07

Brief Summary

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This study aims to find easy-to-measure biomarkers of intestinal permeability as surrogate markers for effortful "gold standard" methods.

Detailed Description

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This study aims to find easy-to-measure biomarkers of intestinal permeability as surrogate markers for effortful "gold standard" methods. In healthy volunteers potential biomarkers for intestinal permeability as well as an established "gold standard" method for intestinal permeability (urinary lactulose/mannitol excretion) will be measured at one time point. Using correlation analyses, potential associations will be assessed and potential biomarkers will be addressed and discussed.

Conditions

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Focus: Simplified Method to Assess Intestinal Permeability

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers
* Written informed consent

Exclusion Criteria

* Underweight (BMI \<18 kg / m2) and obesity from grade II (BMI ≥ 30 kg / m2)
* Acute or chronic gastrointestinal diseases
* Chronically consuming diseases (e.g. chronic tumor disease, florid infections, etc.)
* Smokers (12 hours before the test and during the test it is not allowed to smoke)
* Ingestion of intestinal therapeutics, antibiotics, immunosuppressants or similar within the last 3 months
* Simultaneous participation in another clinical study
* Pregnancy / breastfeeding
* Intolerance to the sugar solution
* Occurrence of relevant diseases
* Revocation of consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Hohenheim

OTHER

Sponsor Role lead

Responsible Party

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Stephan C. Bischoff, MD, Professor

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stephan C Bischoff, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Hohenheim, Institute of Nutritional Medicine

Locations

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University of Hohenheim

Stuttgart, , Germany

Site Status

Countries

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Germany

Other Identifiers

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Gut barrier study

Identifier Type: -

Identifier Source: org_study_id

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