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

University of Erlangen-Nürnberg Medical School

Status: Unknown

Conditions: Inflammatory Bowel Diseases

Treatments: Other: Recording of major clinical events

Study type: Observational

Funder types: Other

Identifiers

NCT05157750

ERIca Study

Details and patient eligibility

About

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.

Full 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

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

180 participants in 3 patient groups

IBD patients with endoscopic remission

Description:

No intervention will be administered. All patients with endoscopic remission will be monitored for the future development of major clinical events. Diagnostic performances of endoscopic remission for predicting major clinical events will be calculated.

Treatment:

Other: Recording of major clinical events

IBD patients with histologic remission

Description:

No intervention will be administered. All patients with histologic remission will be monitored for the future development of major clinical events. Diagnostic performances of histologic remission for predicting major clinical events will be calculated.

Treatment:

Other: Recording of major clinical events

IBD patients with barrier healing

Description:

No intervention will be administered. All patients with barrier healing will be monitored for the future development of major clinical events. Diagnostic performances of barrier healing for predicting major clinical events will be calculated.

Treatment:

Other: Recording of major clinical events