Focus: Simplified Method to Assess Intestinal Permeability Clinical Trial
Official title:
Pilot Study: Validation of Easy-to-measure Biomarkers for Intestinal Permeability in Human Trials
Verified date | January 2021 |
Source | University of Hohenheim |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study aims to find easy-to-measure biomarkers of intestinal permeability as surrogate markers for effortful "gold standard" methods.
Status | Completed |
Enrollment | 51 |
Est. completion date | January 7, 2021 |
Est. primary completion date | December 1, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | University of Hohenheim | Stuttgart |
Lead Sponsor | Collaborator |
---|---|
University of Hohenheim |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lactulose / mannitol ratio | Urinary excretion of lactulose and mannitol | 1 day (Single measurement) | |
Secondary | Fecal albumin [ng/mg] | Potential easy-to-measure biomarker #1 | 1 day (Single measurement) | |
Secondary | Fecal calprotectin [ng/mg] | Potential easy-to-measure biomarker #2 | 1 day (Single measurement) | |
Secondary | Fecal zonulin [ng/mg] | Potential easy-to-measure biomarker #3 | 1 day (Single measurement) | |
Secondary | Plasma lipopolysaccharide binding protein [µg/ml] | Potential easy-to-measure biomarker #4 | 1 day (Single measurement) |