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

• Conditions: Inflammatory Bowel Diseases
• Interventions: Other: Recording of major clinical events

• Registration Number: NCT05157750
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

Brief 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.

Detailed 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 Timeline

• Study Start: 2017-01-16
• Study First Submitted: 2021-10-19
• Status Verified: 2021-12
• Study First Submitted QC: 2021-12-14
• Last Update Submitted: 2021-12-14
• Study First Posted: 2021-12-15
• Last Update Posted: 2021-12-15
• Primary Completion: 2022-04-01
• Study Completion: 2022-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IBD patients with endoscopic remission	Recording of major clinical events	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.
IBD patients with barrier healing	Recording of major clinical events	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.
IBD patients with histologic remission	Recording of major clinical events	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.

Primary Outcome Measures

Name	Time	Method
Predictive value of endoscopic remission in Crohn's disease	2 years	Endoscopic remission will be assessed using the simplified endoscopic index of severity (SES-CD) in Crohn's disease
Predictive value of histologic remission in Crohn's disease	2 years	Histologic remission will be assessed using a modified Riley Score in Crohn's disease
Predictive value of endoscopic remission in ulcerative colitis	2 years	Endoscopic remission will be assessed using the Mayo Endoscopy Score in ulcerative colitis
Predictive value of barrier healing	2 years	Barrier healing will be assessed using the well-established Watson-Score as a semiquantitative grading system of the intestinal barrier function
Predictive value of histologic remission in ulcerative colitis	2 years	Histologic remission will be assessed using the Robarts Histology Index and the Nancy Histology Index in ulcerative colitis

Trial Locations

Locations (1)

University Hospital Erlangen; 🇩🇪 Erlangen, Germany