NCT04849936

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Universität Duisburg-Essen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-07-13
• Primary completion: 2023-07-01
• Completion: 2023-08-01
• First posted: 2021-04-19
• Last updated: 2022-05-18

Locations

1 site across 1 country: Germany