Biomarkers for Intestinal Permeability | NCT04667208

Studies
Biomarkers for Intestinal Permeability

NCT04667208

Sponsor

University of Hohenheim

Status

Completed

Last Update Posted

Jan 26, 2021Actual

Enrollment

51Actual

Phase

Not provided

Conditions

Focus: Simplified Method to Assess Intestinal Permeability

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2020Actual

Primary Completion Date

Dec 1, 2020Actual

Completion Date

Jan 7, 2021Actual

First Submitted Date

Dec 8, 2020

First Submission Date that Met QC Criteria

Dec 11, 2020

First Posted Date

Dec 14, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 25, 2021

Last Update Posted Date

Jan 26, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

51Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Fecal albumin [ng/mg]	Potential easy-to-measure biomarker #1	1 day (Single measurement)
Fecal calprotectin [ng/mg]	Potential easy-to-measure biomarker #2

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Healthy volunteers

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stephan C Bischoff, Prof. Dr.	University of Hohenheim, Institute of Nutritional Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Hohenheim		Stuttgart		70599	Germany