Biomarkers for Intestinal Permeability

January 25, 2021 updated by: Stephan C. Bischoff, MD, Professor, University of Hohenheim

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

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

51

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Stuttgart, Germany, 70599
        • University of Hohenheim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy volunteers

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Hohenheim

Investigators

  • Principal Investigator: Stephan C Bischoff, Prof. Dr., University of Hohenheim, Institute of Nutritional Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

January 7, 2021

Study Registration Dates

First Submitted

December 8, 2020

First Submitted That Met QC Criteria

December 11, 2020

First Posted (Actual)

December 14, 2020

Study Record Updates

Last Update Posted (Actual)

January 26, 2021

Last Update Submitted That Met QC Criteria

January 25, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Gut barrier study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Focus: Simplified Method to Assess Intestinal Permeability

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe