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

• Conditions: Inflammatory Bowel Diseases
• Interventions: Diagnostic Test: Testing Fecal Biomarkers In Comparison To Endoscopic Examination With Confocal Laser Endomicroscopy

• Registration Number: NCT04849936
• Lead Sponsor: Universität Duisburg-Essen

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.

Study Timeline

• Study Start: 2020-07-13
• Study First Submitted: 2020-10-02
• Study First Submitted QC: 2021-04-16
• Study First Posted: 2021-04-19
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-17
• Last Update Posted: 2022-05-18
• Primary Completion: 2023-07
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
evaluation of fecal biomarkers	Testing Fecal Biomarkers In Comparison To Endoscopic Examination With Confocal Laser Endomicroscopy	comparison of the biomarker levels between different gastrointestinal diseases

Primary Outcome Measures

Name	Time	Method
correlation analyses	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.

Trial Locations

Locations (1)

Sozialstiftung Bamberg, Klinik für Intergrative Medizin; 🇩🇪 Bamberg, Bayern, Germany