- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04667208
Biomarkers for Intestinal Permeability
January 25, 2021 updated by: Stephan C. Bischoff, MD, Professor, University of Hohenheim
Pilot Study: Validation of Easy-to-measure Biomarkers for Intestinal Permeability in Human Trials
This study aims to find easy-to-measure biomarkers of intestinal permeability as surrogate markers for effortful "gold standard" methods.
Study Overview
Status
Completed
Detailed Description
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.
Study Type
Observational
Enrollment (Actual)
51
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Stuttgart, Germany, 70599
- University of Hohenheim
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy volunteers
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lactulose / mannitol ratio
Time Frame: 1 day (Single measurement)
|
Urinary excretion of lactulose and mannitol
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1 day (Single measurement)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fecal albumin [ng/mg]
Time Frame: 1 day (Single measurement)
|
Potential easy-to-measure biomarker #1
|
1 day (Single measurement)
|
Fecal calprotectin [ng/mg]
Time Frame: 1 day (Single measurement)
|
Potential easy-to-measure biomarker #2
|
1 day (Single measurement)
|
Fecal zonulin [ng/mg]
Time Frame: 1 day (Single measurement)
|
Potential easy-to-measure biomarker #3
|
1 day (Single measurement)
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Plasma lipopolysaccharide binding protein [µg/ml]
Time Frame: 1 day (Single measurement)
|
Potential easy-to-measure biomarker #4
|
1 day (Single measurement)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Stephan C Bischoff, Prof. Dr., University of Hohenheim, Institute of Nutritional Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2020
Primary Completion (Actual)
December 1, 2020
Study Completion (Actual)
January 7, 2021
Study Registration Dates
First Submitted
December 8, 2020
First Submitted That Met QC Criteria
December 11, 2020
First Posted (Actual)
December 14, 2020
Study Record Updates
Last Update Posted (Actual)
January 26, 2021
Last Update Submitted That Met QC Criteria
January 25, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- Gut barrier study
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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