Biomarkers for Intestinal Permeability

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04667208
• Other study ID #: Gut barrier study
• Status: Completed
• Start date: September 1, 2020
• Est. completion date: January 7, 2021

Study information

• Verified date: January 2021
• Source: University of Hohenheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Focus: Simplified Method to Assess Intestinal Permeability

Locations

Country	Name	City	State
Germany	University of Hohenheim	Stuttgart

Sponsors (1)

Lead Sponsor	Collaborator
University of Hohenheim

Country where clinical trial is conducted

Germany, 

Outcome

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)