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

Inflammatory Bowel Diseases Clinical Trial

— ERIca  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05157750
• Other study ID #: ERIca Study
• Status: Recruiting
• Start date: January 16, 2017
• Est. completion date: May 1, 2022

Study information

• Verified date: December 2021
• Source: University of Erlangen-Nürnberg Medical School
• Contact: Timo Rath, MD
• Phone: +49 913185-35000
• Email: timo.rath[@]uk-erlangen.de
• Is FDA regulated: No
• Study type: Observational

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: May 1, 2022
• Est. primary completion date: April 1, 2022
• 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

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases

Intervention

Other:
• Recording of major clinical events
During follow-up, major clinical events, 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.

Locations

Country	Name	City	State
Germany	University Hospital Erlangen	Erlangen

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

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