Pilot Study: Validation of Easy-to-measure Biomarkers for Intestinal Permeability in Human Trials
| Registry | NCT04667208 |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 51 (Actual) |
| Sponsor | University of Hohenheim (Other) |
| Conditions | Focus: Simplified Method to Assess Intestinal Permeability |
| Dates | start 2020-09-01, primary completion 2020-12-01, completion 2021-01-07, first posted 2020-12-14, last updated 2021-01-26 |
| Locations | 1 site in Germany |
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All trials for Focus: Simplified Method to Assess Intestinal Permeability
This study aims to find easy-to-measure biomarkers of intestinal permeability as surrogate markers for effortful "gold standard" methods.
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.
Sex: All, ages: 18 Years to 70 Years, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| University of Hohenheim | Stuttgart | Germany |