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

NCT04849936 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2022-05-18

No results posted yet for this study

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.

Conditions

  • Inflammatory Bowel Diseases

Interventions

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.

Sponsors & Collaborators

  • Sozialstiftung Bamberg

    collaborator OTHER

  • Enterosan Labor LS SE & Co.KG

    collaborator UNKNOWN

  • Universität Duisburg-Essen

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-13
Primary Completion
2023-07-31
Completion
2023-08-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04849936 on ClinicalTrials.gov