A Diagnostic Accuracy Study Testing Fecal Biomarkers In Comparison To Endoscopic Examination
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Inflammatory Bowel Diseases
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 d...
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.
Tracking Information
- NCT #
- NCT04849936
- Collaborators
- Sozialstiftung Bamberg
- Enterosan Labor LS SE & Co.KG
- Investigators
- Not Provided