Biomarkers for Intestinal Permeability

Completed

• Conditions: Focus: Simplified Method to Assess Intestinal Permeability

• Registration Number: NCT04667208
• Lead Sponsor: University of Hohenheim

Brief Summary

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

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 Timeline

• Study Start: 2020-09-01
• Primary Completion: 2020-12-01
• Study First Submitted: 2020-12-08
• Study First Submitted QC: 2020-12-11
• Study First Posted: 2020-12-14
• Status Verified: 2021-01
• Study Completion: 2021-01-07
• Last Update Submitted: 2021-01-25
• Last Update Posted: 2021-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Lactulose / mannitol ratio	1 day (Single measurement)	Urinary excretion of lactulose and mannitol

Secondary Outcome Measures

Name	Time	Method
Fecal albumin [ng/mg]	1 day (Single measurement)	Potential easy-to-measure biomarker #1
Fecal calprotectin [ng/mg]	1 day (Single measurement)	Potential easy-to-measure biomarker #2
Fecal zonulin [ng/mg]	1 day (Single measurement)	Potential easy-to-measure biomarker #3
Plasma lipopolysaccharide binding protein [µg/ml]	1 day (Single measurement)	Potential easy-to-measure biomarker #4

Trial Locations

Locations (1)

University of Hohenheim; 🇩🇪 Stuttgart, Germany