Inflammatory Bowel Diseases Clinical Trial
— ERIcaOfficial title:
Direct Comparison of Endoscopic and Histologic Remission and Barrier Healing for Predicting Long Term Disease Behaviour in Clinically Remittent IBD Patients: the Prospective ERIca Study
NCT number | NCT05157750 |
Other study ID # | ERIca Study |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 16, 2017 |
Est. completion date | May 1, 2022 |
Within this study, the investigators aim to directly compare the value of endoscopic remission, histologic remission and barrier healing for predicting long-term disease behavior in a large cohort of clinically remittent IBD patients.
Status | Recruiting |
Enrollment | 180 |
Est. completion date | May 1, 2022 |
Est. primary completion date | April 1, 2022 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: - patients with an established IBD diagnosis for at least 12 months duration - IBD patients in clinical remission Exclusion Criteria: - patients with poor bowel preparation - patients with total colectomy, - patients with concomitant beta blocker therapy, - patients with known allergy to fluorescein - patients with a planned change in IBD-related pharmacotherapy |
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital Erlangen | Erlangen |
Lead Sponsor | Collaborator |
---|---|
University of Erlangen-Nürnberg Medical School |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Predictive value of endoscopic remission in ulcerative colitis | Endoscopic remission will be assessed using the Mayo Endoscopy Score in ulcerative colitis | 2 years | |
Primary | Predictive value of endoscopic remission in Crohn's disease | Endoscopic remission will be assessed using the simplified endoscopic index of severity (SES-CD) in Crohn's disease | 2 years | |
Primary | Predictive value of histologic remission in ulcerative colitis | Histologic remission will be assessed using the Robarts Histology Index and the Nancy Histology Index in ulcerative colitis | 2 years | |
Primary | Predictive value of histologic remission in Crohn's disease | Histologic remission will be assessed using a modified Riley Score in Crohn's disease | 2 years | |
Primary | Predictive value of barrier healing | Barrier healing will be assessed using the well-established Watson-Score as a semiquantitative grading system of the intestinal barrier function | 2 years |
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