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

NCT05157750 | Unknown

• 1 other identifier: ERIca Study
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (5)

• Predictive value of endoscopic remission in ulcerative colitis

  Endoscopic remission will be assessed using the Mayo Endoscopy Score in ulcerative colitis

  2 years

• 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

• 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

• 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

• 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

Study Arms (3)

IBD patients with endoscopic remission

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.

Other: Recording of major clinical events

IBD patients with histologic remission

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.

Other: Recording of major clinical events

IBD patients with barrier healing

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.

Other: Recording of major clinical events

Interventions

Recording of major clinical events OTHER

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.

IBD patients with barrier healing; IBD patients with endoscopic remission; IBD patients with histologic remission

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients with an established IBD diagnosis for at least 12 months duration presenting in clinical remission presenting at the Department of Gastroenterology of the University Hospital Erlangen will be prospectively included.

You may qualify if:

• patients with an established IBD diagnosis for at least 12 months duration
• IBD patients in clinical remission

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

University Hospital Erlangen

Erlangen, 91054, Germany

RECRUITING

Related Publications (2)

• Rath T, Atreya R, Bodenschatz J, Uter W, Geppert CI, Vitali F, Zundler S, Waldner MJ, Hartmann A, Neurath MF. Healing of the epithelial barrier in the ileum is superior to endoscopic and histologic remission for predicting major adverse outcomes in ulcerative colitis. Front Med (Lausanne). 2023 Oct 10;10:1221449. doi: 10.3389/fmed.2023.1221449. eCollection 2023.

  PMID: 37881628 DERIVED

• Rath T, Atreya R, Bodenschatz J, Uter W, Geppert CE, Vitali F, Fischer S, Waldner MJ, Colombel JF, Hartmann A, Neurath MF. Intestinal Barrier Healing Is Superior to Endoscopic and Histologic Remission for Predicting Major Adverse Outcomes in Inflammatory Bowel Disease: The Prospective ERIca Trial. Gastroenterology. 2023 Feb;164(2):241-255. doi: 10.1053/j.gastro.2022.10.014. Epub 2022 Oct 21.

  PMID: 36279923 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Timo Rath, MD

  University Hospital Erlangen, Department of Medicine 1

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Timo Rath, MD

CONTACT

+49 913185-35000; timo.rath@uk-erlangen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor for Endoscopy, Consultant in Gastroenterology

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: December 15, 2021
• Study Start: January 16, 2017
• Primary Completion: April 1, 2022
• Study Completion: May 1, 2022
• Last Updated: December 15, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)