Biomarkers for Intestinal Permeability

NCT04667208 — Completed, 51 participants, University of Hohenheim

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

RegistryNCT04667208
StatusCompleted
Study typeObservational
Enrollment51 (Actual)
SponsorUniversity of Hohenheim (Other)
ConditionsFocus: Simplified Method to Assess Intestinal Permeability
Datesstart 2020-09-01, primary completion 2020-12-01, completion 2021-01-07, first posted 2020-12-14, last updated 2021-01-26
Locations1 site in Germany

Related Papers Related Patents Related Grants Related Experts
All trials for Focus: Simplified Method to Assess Intestinal Permeability

-Summary

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

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+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.

+Outcome measures

Primary outcomes

  • Lactulose / mannitol ratio [1 day (Single measurement)]: Urinary excretion of lactulose and mannitol

Secondary outcomes

  • 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

+Eligibility

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

+Locations (1)

FacilityCityCountryStatus
University of HohenheimStuttgartGermany

+Investigators