Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04849936
Other study ID # 20025
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 13, 2020
Est. completion date August 2023

Study information

Verified date May 2022
Source Universität Duisburg-Essen
Contact Jost Langhorst, Prof.
Phone 0049951-50311251
Email jost.langhorst@sozialstiftung-bamberg.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date August 2023
Est. primary completion date July 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Germany Sozialstiftung Bamberg, Klinik für Intergrative Medizin Bamberg Bayern

Sponsors (3)

Lead Sponsor Collaborator
Universität Duisburg-Essen Enterosan Labor LS SE & Co.KG, Sozialstiftung Bamberg

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary correlation analyses 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.
data of biomarkers generated two weeks before or two weeks after the gastroscopy and/or coloscopy
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04046913 - The ADDapt Diet in Reducing Crohn's Disease Inflammation N/A
Active, not recruiting NCT04989907 - A Study in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) Receiving Vedolizumab in Real-World Practice in Switzerland
Recruiting NCT05316584 - A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy N/A
Active, not recruiting NCT04990258 - A 24-month Real Life PErsistence Efficacy and Safety Study in IBD Patients in REMission Switched From Intravenous Infliximab to Subcutaneous Infliximab CT-P13 Remsima®SC
Completed NCT06216223 - Laser Versus Surgery in Anal Diseases in Inflammatory Bowel Patients N/A
Enrolling by invitation NCT06015789 - Self-care in Patients Affected by Inflammatory Bowel Disease and Caregivers' Contribution to Self-care
Recruiting NCT06065995 - StoMakker Mobile Application N/A
Recruiting NCT03282786 - Comparison of Carbon Dioxide (CO2) to Air Insufflation in Colonoscopy in Patients With Inflammatory Bowel Disease N/A
Recruiting NCT06002074 - SMART Program Impact on Quality of Life in Inflammatory Bowel Diseases N/A
Recruiting NCT04960826 - Study of an Environmental Risk Factor in Crohn's Disease
Recruiting NCT05413941 - Internet-based Cognitive Behavioral Therapy in Inflammatory Bowel Disease N/A
Completed NCT03668249 - A Study to Characterize Multidimensional Model to Predict the Course of Crohn's Disease (CD)
Completed NCT00721812 - A First Time In Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686 Phase 1
Recruiting NCT05809999 - IBD Neoplasia Surveillance RCT N/A
Recruiting NCT04138225 - The Ecological Role of Yeasts in the Human Gut
Recruiting NCT04991324 - Cholecalciferol Comedication in IBD - the 5C-study Phase 3
Completed NCT03173144 - Chronic Inflammatory Disease, Lifestyle and Treatment Response
Not yet recruiting NCT05043818 - A Clinical Study on the Screening of Intestinal Biomarkers in IBD Patients With Depression
Recruiting NCT03042091 - Neomycin and Metronidazole Hydrochloride With or Without Polyethylene Glycol in Reducing Infection in Patients Undergoing Elective Colorectal Surgery Early Phase 1
Not yet recruiting NCT02858557 - The Effect of Diet on Microbial Profile and Disease Outcomes in Patients With Inflammatory Bowel Diseases N/A