Endoscopic Remission, Histologic Remission and Barrier Healing for Predicting Disease Behaviour in IBD
NCT ID: NCT05157750
Last Updated: 2021-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
180 participants
OBSERVATIONAL
2017-01-16
2022-05-01
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* IBD patients in clinical remission
Exclusion Criteria
* 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
18 Years
99 Years
ALL
No
Sponsors
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University of Erlangen-Nürnberg Medical School
OTHER
Responsible Party
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Timo Rath
Professor for Endoscopy, Consultant in Gastroenterology
Principal Investigators
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Timo Rath, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Erlangen, Department of Medicine 1
Locations
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University Hospital Erlangen
Erlangen, , Germany
Countries
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Central Contacts
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Facility Contacts
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Timo Rath, M.D.
Role: primary
References
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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.
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.
Other Identifiers
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ERIca Study
Identifier Type: -
Identifier Source: org_study_id