Clinical trial NCT04849936: A Diagnostic Accuracy Study Testing Fecal Biomarkers In Comparison To Endoscopic Examination
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inflammatory Bowel Diseases
Keywords: inflammatory bowel diseases
fecal biomarkers
calprotectin
lactoferrin
pmn-elastase
human beta-defensin
zonulin
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
Collaborators: name: Sozialstiftung Bamberg
name: Enterosan Labor LS SE & Co.KG
First posted: 2021-04-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: correlation analyses
timeFrame: data of biomarkers generated two weeks before or two weeks after the gastroscopy and/or coloscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Bamberg
country: Germany
facility: Sozialstiftung Bamberg, Klinik für Intergrative Medizin
state: Bayern
Study officials:
References: