Inflammatory Bowel DiseasesNCT04849936
A Diagnostic Accuracy Study Testing Fecal Biomarkers In Comparison To Endoscopic Examination
An observational study of Inflammatory Bowel Diseases, run by Universität Duisburg-Essen at 1 site in Germany.
Trial summary
In this study it will be explored whether the levels of fecal biomarkers are associated with histologic inflammation of the intestinal mucosa and concomitant alteration of the mucosal permeability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Testing Fecal Biomarkers In Comparison To Endoscopic Examination With Confocal Laser Endomicroscopy
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- 13 Jul 2020to Aug 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of patients with inflammatory bowel disease, patients with symptomatic non-inflammatory bowel disease, and patients with other gastrointestinal diseases who routinely undergo endoscopic examination at the center in the form of endoscopy with tissue biopsies with and without confocal laser endomicroscopy.
Who may be able to join
- Adults
- Signed declaration of consent
- Presence of a confirmed diagnosis of
- Inflammatory bowel diseases
- Irritable bowel syndrome
- Gastrointestinal diseases, except participants with diagnosis of group 1 or 2 (e.g. celiac disease, food allergies, microscopic colitis, diverticulosis, diverticulitis)
- Healthy controls as part of a preventive medical check-up
Who cannot join
- No indication for endoscopic examination as part of routine care
- Age under 18 years
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Sozialstiftung Bamberg, Klinik für Intergrative Medizin
Bamberg, Bavaria, 96049
Jost Langhorst, Prof., 0049951-503-11251, jost.langhorst@sozialstiftung-bamberg.de
Özlem Öznur, 0049951-503-16936, oezlem.oeznur@sozialstiftung-bamberg.de
About this study
Official title: Diagnostische Genauigkeit fäkaler Biomarker im Vergleich Zur Endoskopie Mit Und Ohne Konfokaler Laserendomikroskopie in Der Routineversorgung Zur Bestimmung Der Entzündungsaktivität Bei Patienten Mit Gastrointestinalen Diagnosen
In this study it will be explored whether the levels of fecal biomarkers are associated with histologic inflammation of the intestinal mucosa and concomitant alteration of the mucosal permeability. The aim of the study is to assess the diagnostic accuracy of fecal biomarkers especially to detect the potential of differentiation between inflammatory and functional gastrointestinal diseases.
The following biomarkers will be examined in the stool of the participants: calprotectin, lactoferrin, pmn-elastase, human beta-defensin, zonulin, alpha-antitrypsin.
Read the detailed description
For this study inpatients and outpatients of the clinic for integrative medicine and naturopathy Bamberg, Germany, who had a routine gastroscopy and/or coloscopy with tissue biopsy or an endoscopy with confocal laser endomicroscopy and tissue biopsy were enclosed.
These patients, who were examined during a routine diagnostics, should submit an extra morning stool sample up to two weeks before or after the gastroscopy and/or coloscopy to generate the data of the fecal biomarker mentioned above.
On the basis of the biopsy samples generated through the routine examination we can determine the histology scores, Nancy Index and Riley Score. The determined scores, the data of the fecal biomarkers and the results of the confocal laser endomicroscopy as well as, if available, more clinical data such as the clinical activity index (CAI), the MAYO-Score/Disease Activity Index (DAI), the endoscopic Rachmilewitz-Index (REI) and the Questionnaire for inflammatory bowel disease (IBDQ) will be anonymised inserted into a SPSS data bank and will then be interpreted.
For the adequate description of the collective data of gender, age, blood levels and medication will be gathered and added to the data bank anonymised.
The calculated data will then be compared with the clinical evaluation of the patients with symptomatic irritable bowel syndrome, active inflammatory bowel diseases and patients with other gastrointestinal diseases.
The aim of this study is to develop improved methods for non invasive diagnostics of gastrointestinal diseases.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Testing Fecal Biomarkers In Comparison To Endoscopic Examination With Confocal Laser Endomicroscopy
- Keywords
- inflammatory bowel diseases, fecal biomarkers, calprotectin, lactoferrin, pmn-elastase, human beta-defensin, zonulin
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testing Fecal Biomarkers In Comparison To Endoscopic Examination With Confocal Laser EndomicroscopyDiagnostic test
Patients, who were examined during a routine diagnostics, should submit an extra morning stool sample up to two weeks before or after the gastroscopy and/or coloscopy to generate the data of the fecal biomarker mentioned above.
| Study group | Role | What they receive |
|---|---|---|
| evaluation of fecal biomarkers | comparison of the biomarker levels between different gastrointestinal diseases Receives: Diagnostic Test: Testing Fecal Biomarkers In Comparison To Endoscopic Examination With Confocal Laser Endomicroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation analyses
Correlation analyses will be performed to determine if there is a correlation between fecal biomarker values and confocal laser endomicroscopy results and histologic scores. If available, correlations between the fecal biomarkers and other parameters such as clinical activity index (CAI), Mayo score/disease activity index (DAI), endoscopic Rachmilewitz index (REI), and inflammatory bowel disease questionnaire (IBDQ) data will also be calculated.
In addition, group comparisons will be performed to test whether fecal biomarkers differ between (1) the different levels of the Nancy index and (2) the classification into "patients in remission" and "patients with disease activity" given according to histological assessment. Receiver operating characteristic (ROC) curves will also be used to determine optimal cut-offs and calculate sensitivity and specificity of fecal biomarkers.
Measured: data of biomarkers generated two weeks before or two weeks after the gastroscopy and/or coloscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start13 Jul 2020
- Primary completionJul 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Collaborators
- Sozialstiftung Bamberg, Enterosan Labor LS SE & Co.KG
- Responsible party
- Principal investigator, Jost Langhorst, Universität Duisburg-Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04849936
- Sponsor's protocol ID
- 20025
- Status last verified
- May 2022
- First submitted
- 2 Oct 2020
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostische Genauigkeit fäkaler Biomarker im Vergleich Zur Endoskopie Mit Und Ohne Konfokaler Laserendomikroskopie in Der Routineversorgung Zur Bestimmung Der Entzündungsaktivität Bei Patienten Mit Gastrointestinalen Diagnosen
- ClinicalTrials.gov ID
- NCT04849936
- Acronym / sponsor ID
- 20025
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- inflammatory bowel diseases, fecal biomarkers, calprotectin, lactoferrin, pmn-elastase, human beta-defensin, zonulin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Collaborators
- Sozialstiftung Bamberg, Enterosan Labor LS SE & Co.KG
- Study start
- 13 Jul 2020 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 19 Apr 2021 (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.
In this study it will be explored whether the levels of fecal biomarkers are associated with histologic inflammation of the intestinal mucosa and concomitant alteration of the mucosal permeability. The aim of the study is to assess the diagnostic accuracy of fecal biomarkers especially to detect the potential of differentiation between inflammatory and functional gastrointestinal diseases.
The following biomarkers will be examined in the stool of the participants: calprotectin, lactoferrin, pmn-elastase, human beta-defensin, zonulin, alpha-antitrypsin.
Detailed description
For this study inpatients and outpatients of the clinic for integrative medicine and naturopathy Bamberg, Germany, who had a routine gastroscopy and/or coloscopy with tissue biopsy or an endoscopy with confocal laser endomicroscopy and tissue biopsy were enclosed.
These patients, who were examined during a routine diagnostics, should submit an extra morning stool sample up to two weeks before or after the gastroscopy and/or coloscopy to generate the data of the fecal biomarker mentioned above.
On the basis of the biopsy samples generated through the routine examination we can determine the histology scores, Nancy Index and Riley Score. The determined scores, the data of the fecal biomarkers and the results of the confocal laser endomicroscopy as well as, if available, more clinical data such as the clinical activity index (CAI), the MAYO-Score/Disease Activity Index (DAI), the endoscopic Rachmilewitz-Index (REI) and the Questionnaire for inflammatory bowel disease (IBDQ) will be anonymised inserted into a SPSS data bank and will then be interpreted.
For the adequate description of the collective data of gender, age, blood levels and medication will be gathered and added to the data bank anonymised.
The calculated data will then be compared with the clinical evaluation of the patients with symptomatic irritable bowel syndrome, active inflammatory bowel diseases and patients with other gastrointestinal diseases.
The aim of this study is to develop improved methods for non invasive diagnostics of gastrointestinal diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| evaluation of fecal biomarkers | – | Diagnostic Test: Testing Fecal Biomarkers In Comparison To Endoscopic Examination With Confocal Laser Endomicroscopycomparison of the biomarker levels between different gastrointestinal diseases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients with inflammatory bowel disease, patients with symptomatic non-inflammatory bowel disease, and patients with other gastrointestinal diseases who routinely undergo endoscopic examination at the center in the form of endoscopy with tissue biopsies with and without confocal laser endomicroscopy.
Key inclusion criteria (7 listed)
- Adults
- Signed declaration of consent
- Presence of a confirmed diagnosis of
Key exclusion criteria (2 listed)
- No indication for endoscopic examination as part of routine care
- Age under 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testing Fecal Biomarkers In Comparison To Endoscopic Examination With Confocal Laser EndomicroscopyPatients, who were examined during a routine diagnostics, should submit an extra morning stool sample up to two weeks before or after the gastroscopy and/or coloscopy to generate the data of the fecal biomarker mentioned above. | Diagnostic test | evaluation of fecal biomarkers |
Primary outcome
correlation analyses
Time frame: data of biomarkers generated two weeks before or two weeks after the gastroscopy and/or coloscopy
Correlation analyses will be performed to determine if there is a correlation between fecal biomarker values and confocal laser endomicroscopy results and histologic scores. If available, correlations between the fecal biomarkers and other parameters such as clinical activity index (CAI), Mayo score/disease activity index (DAI), endoscopic Rachmilewitz index (REI), and inflammatory bowel disease questionnaire (IBDQ) data will also be calculated. In addition, group comparisons will be performed to test whether fecal biomarkers differ between (1) the different levels of the Nancy index and (2) the classification into "patients in remission" and "patients with disease activity" given according to histological assessment. Receiver operating characteristic (ROC) curves will also be used to determine optimal cut-offs and calculate sensitivity and specificity of fecal biomarkers.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
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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.
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 Inflammatory Bowel Diseases, run by Universität Duisburg-Essen 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 7 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 18 May 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jost Langhorst, Prof. (0049951-50311251, jost.langhorst@sozialstiftung-bamberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation analyses (time frame: data of biomarkers generated two weeks before or two weeks after the gastroscopy and/or coloscopy). 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 18 May 2022.