Biomarkers for Intestinal Permeability

Pilot Study: Validation of Easy-to-measure Biomarkers for Intestinal Permeability in Human Trials

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04667208

Enrollment

Registered

2020-12-14

Start date

2020-09-01

Completion date

2021-01-07

Last updated

2021-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Focus: Simplified Method to Assess Intestinal Permeability

Keywords

Gastroenterology, Gut barrier, Intestinal permeability

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Lactulose / mannitol ratio	1 day (Single measurement)	Urinary excretion of lactulose and mannitol

Secondary

Measure	Time frame	Description
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

Countries

Germany

Outcome results