Focus: Simplified Method to Assess Intestinal PermeabilityNCT04667208
Biomarkers for Intestinal Permeability
An observational study of Focus: Simplified Method to Assess Intestinal Permeability, run by University of Hohenheim at 1 site in Germany.
Trial summary
This study aims to find easy-to-measure biomarkers of intestinal permeability as surrogate markers for effortful "gold standard" methods. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Focus: Simplified Method to Assess Intestinal Permeability
- How many people
- 51 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2020to 7 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers
Who may be able to join
- Healthy volunteers
- Written informed consent
Who cannot join
- 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
Show all 10Show fewer
- Pregnancy / breastfeeding
- Intolerance to the sugar solution
- Occurrence of relevant diseases
- Revocation of consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Keywords
- Gastroenterology, Gut barrier, Intestinal permeability
What is being measured
The primary outcome is the main question the study is designed to answer.
Lactulose / mannitol ratio
Urinary excretion of lactulose and mannitol
Measured: 1 day (Single measurement)
Secondary outcomes (4)
Fecal albumin [ng/mg]
Potential easy-to-measure biomarker #1
Measured: 1 day (Single measurement)
Fecal calprotectin [ng/mg]
Potential easy-to-measure biomarker #2
Measured: 1 day (Single measurement)
Fecal zonulin [ng/mg]
Potential easy-to-measure biomarker #3
Measured: 1 day (Single measurement)
Plasma lipopolysaccharide binding protein [µg/ml]
Potential easy-to-measure biomarker #4
Measured: 1 day (Single measurement)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start1 Sep 2020
- Primary completion1 Dec 2020
- Study completion7 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus: Simplified Method to Assess Intestinal PermeabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hohenheim
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephan C. Bischoff, MD, Professor, University of Hohenheim
- Investigators
- Stephan C Bischoff, Prof. Dr., Principal investigator, University of Hohenheim, Institute of Nutritional Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04667208
- Sponsor's protocol ID
- Gut barrier study
- Status last verified
- Jan 2021
- First submitted
- 8 Dec 2020
- Last updated
- 26 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Validation of Easy-to-measure Biomarkers for Intestinal Permeability in Human Trials
- ClinicalTrials.gov ID
- NCT04667208
- Acronym / sponsor ID
- Gut barrier study
- Keywords
- Gastroenterology, Gut barrier, Intestinal permeability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of HohenheimUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 7 Jan 2021 (actual)
- First posted
- 14 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers
Key inclusion criteria (2 listed)
- Healthy volunteers
- Written informed consent
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Lactulose / mannitol ratio
Time frame: 1 day (Single measurement)
Urinary excretion of lactulose and mannitol
4 secondary outcomes
Fecal albumin [ng/mg]
Time frame: 1 day (Single measurement)
Fecal calprotectin [ng/mg]
Time frame: 1 day (Single measurement)
Fecal zonulin [ng/mg]
Time frame: 1 day (Single measurement)
Plasma lipopolysaccharide binding protein [µg/ml]
Time frame: 1 day (Single measurement)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan C Bischoff, Prof. Dr. principal investigator
University of Hohenheim, Institute of Nutritional Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Focus: Simplified Method to Assess Intestinal Permeability, run by University of Hohenheim at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lactulose / mannitol ratio (time frame: 1 day (Single measurement)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2021.