NCT04667208

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 14, 2020

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2021

Completed
Last Updated

January 26, 2021

Status Verified

January 1, 2021

Enrollment Period

3 months

First QC Date

December 8, 2020

Last Update Submit

January 25, 2021

Conditions

Focus: Simplified Method to Assess Intestinal Permeability

Keywords

GastroenterologyGut barrierIntestinal permeability

Outcome Measures

Primary Outcomes (1)

  • Lactulose / mannitol ratio

    Urinary excretion of lactulose and mannitol

    1 day (Single measurement)

Secondary Outcomes (4)

  • Fecal albumin [ng/mg]

    1 day (Single measurement)

  • Fecal calprotectin [ng/mg]

    1 day (Single measurement)

  • Fecal zonulin [ng/mg]

    1 day (Single measurement)

  • Plasma lipopolysaccharide binding protein [µg/ml]

    1 day (Single measurement)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteers

You may qualify if:

  • Healthy volunteers
  • Written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hohenheim

Stuttgart, 70599, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma, serum and fecal samples will be stored at -80°C.

Study Officials

  • Stephan C Bischoff, Prof. Dr.

    University of Hohenheim, Institute of Nutritional Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

December 8, 2020

First Posted

December 14, 2020

Study Start

September 1, 2020

Primary Completion

December 1, 2020

Study Completion

January 7, 2021

Last Updated

January 26, 2021

Record last verified: 2021-01

Locations

DE(1)