A Diagnostic Accuracy Study Testing Fecal Biomarkers In Comparison To Endoscopic Examination

Inflammatory Bowel Diseases Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04849936
• Other study ID #: 20025
• Status: Recruiting
• Start date: July 13, 2020
• Est. completion date: August 2023

Study information

• Verified date: May 2022
• Source: Universität Duisburg-Essen
• Contact: Jost Langhorst, Prof.
• Phone: 0049951-50311251
• Email: jost.langhorst[@]sozialstiftung-bamberg.de
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: August 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults

• Signed declaration of consent

• Presence of a confirmed diagnosis of

1. Inflammatory bowel diseases

2. Irritable bowel syndrome

3. Gastrointestinal diseases, except participants with diagnosis of group 1 or 2 (e.g. celiac disease, food allergies, microscopic colitis, diverticulosis, diverticulitis)

4. Healthy controls as part of a preventive medical check-up

Exclusion Criteria:

• No indication for endoscopic examination as part of routine care

• Age under 18 years

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Diagnostic Test:
• Testing Fecal Biomarkers In Comparison To Endoscopic Examination With Confocal Laser Endomicroscopy
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.

Locations

Country	Name	City	State
Germany	Sozialstiftung Bamberg, Klinik für Intergrative Medizin	Bamberg	Bayern

Sponsors (3)

Lead Sponsor	Collaborator
Universität Duisburg-Essen	Enterosan Labor LS SE & Co.KG, Sozialstiftung Bamberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	data of biomarkers generated two weeks before or two weeks after the gastroscopy and/or coloscopy