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OpenTrials
Completed

NCT Number: NCT04667208

Biomarkers for Intestinal Permeability

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

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Key information

Conditions

Focus: Simplified Method to Assess Intestinal Permeability

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Hohenheim

Stuttgart, 70599, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Lactulose / mannitol ratio

    Time frame: 1 day (Single measurement)

    Urinary excretion of lactulose and mannitol

Secondary outcomes

  1. Fecal albumin [ng/mg]

    Time frame: 1 day (Single measurement)

    Potential easy-to-measure biomarker #1

  2. Fecal calprotectin [ng/mg]

    Time frame: 1 day (Single measurement)

    Potential easy-to-measure biomarker #2

  3. Fecal zonulin [ng/mg]

    Time frame: 1 day (Single measurement)

    Potential easy-to-measure biomarker #3

  4. Plasma lipopolysaccharide binding protein [µg/ml]

    Time frame: 1 day (Single measurement)

    Potential easy-to-measure biomarker #4

Sponsors and collaborators

Lead sponsor

University of Hohenheim

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Dec 14, 2020
Registry last updated
Jan 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.