Endoscopic Remission, Histologic Remission & Barrier Healing for

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

Mucosal healing is a key therapeutic goal in the management of patients with inflammatory bowel diseases (IBD) that is associated with favorable long-term disease outcome. In addition, histologic remission is an emerging endpoint and first data suggest that functional assessment of the integrity of the intestinal barrier, i.e. barrier healing, by confocal laser endomicroscopy (CLE) correlates to clinical disease behavior and outcome. Within this study, the investigators will prospectively include IBD patients in clinical remission and assess endoscopic remission, histologic remission and barrier healing during baseline ileocolonoscopy. Participants will then be closely followed up in the IBD outpatient department of the University Hospital Erlangen every 4 to 8 weeks for participants under biological therapy and every 8 weeks for participants under conventional therapy. At each visit, clinical disease activity using the Mayo Clinical Score (MCS) and the Crohn's disease activity Index (CDAI), respectively, routine laboratory parameters and current and past medications will be recorded. Further, at each visit, major clinical events (MCE), defined as (i) disease flare; (ii) IBD-related hospitalization, (iii) IBD-related surgery, (iv) necessity for initiation of systemic steroids, immunosuppressants or biologics; (v) necessity for escalation of an existing biological therapy, will be recorded. The primary endpoint of this study is to comparatively assess the predictive values of barrier healing, endoscopic remission and histologic remission for predicting occurrence of MCE in IBD patients in clinical remission ;

Study Design

Related Conditions & MeSH terms

Inflammatory Bowel Diseases

Clinical Trial Details

NCT number	NCT05157750
Study type	Observational
Source	University of Erlangen-Nürnberg Medical School
Contact	Timo Rath, MD
Phone	+49 913185-35000
Email	timo.rath@uk-erlangen.de
Status	Recruiting
Phase
Start date	January 16, 2017
Completion date	May 1, 2022

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Endoscopic Remission, Histologic Remission and Barrier Healing for Predicting Disease Behaviour in IBD — ERIca

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms