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Inflammatory bowel disease (IBD) encompasses two major forms of chronic intestinal disorders, Crohn's disease and ulcerative colitis (UC). Diagnosis is based on several macroscopic and histologic features including patterns of inflammation, crypt abscesses and granulomas. Confocal laser endomicroscopy (CLE) is rapidly emerging as a valuable tool for gastrointestinal endoscopic imaging, enabling the endoscopist to obtain an "optical biopsy" of the gastrointestinal mucosa during the endoscopic procedure.
The main objective of this study is to determine endomicroscopic features of mucosal healing in patients with IBD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crohn´s disease - active | Patients with Crohn´s disease in the active phase. |
| |
| Crohn´s disease - quiescent | Patients with Crohn´s disease in the quiescent phase. |
| |
| Ulcerative colitis - active | Patients with ulcerative colitis in the active stage. |
| |
| Ucerative colitis - quiescent | Patients with ulcerative colitis in the quiescent stage. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endomicroscopy | Device | Patients will undergo advanced endoscopic imaging using endomicroscopy. Findings will be compared to histopathological and clinical results. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mucosal healing | We will determine endomicroscopic features of mucosal inflammation (e.g. goblet cell depletion, leackage, microvessel density) in IBD in order to establish a new endoscopic classification of mucosal healing. | up to three years |
| Measure | Description | Time Frame |
|---|---|---|
| Histologic correlation | Comparison of clinical and histopathological data with endoscopic findings to evaluate mucosal healing as a parameter of remission and relapse in patients with IBD. | up to three years |
| Therapeutic effect |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with Crohn´s disease and ulcerative colitis in the active and quiescent phase of the disease.
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| Name | Affiliation | Role |
|---|---|---|
| Helmut Neumann, Professor | Department of Medicine I, University of Erlangen-Nuremberg, Germany | Principal Investigator |
| Markus F. Neurath, Professor | Department of Medicine I, University of Erlangen-Nuremberg, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Erlangen-Nuremberg | Erlangen | 91054 | Germany |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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We will evaluate the effect of different therapeutic strategies (eg. anti-TNF treatment) on characteristics of mucosal healing (e.g. goblet cell depletion, microvessels, leakage).
| up to three years |
| D007410 | Intestinal Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |