Endomicroscopy in IBD Patients
EARLY
Endomicroscopy for Assessment of Structural and Functional Changes in IBD Patients Treated With Anti-TNFalpha - Insights in the Process in Mucosal Healing
1 other identifier
observational
50
1 country
1
Brief Summary
The aim of the study is to analyze the mechanism of action of infliximab at the endomicroscopic level and to analyze mucosal healing - i.e. structural and functional changes in the mucosa in IBD patients - and associated processes such as permeability and bacterial invasion of the mucosa. In this study the role of the above mentioned parameters and further the establishment of endomicroscopic scores will serve to define new prognostic markers in view of long term remission upon infliximab treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2011
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 15, 2011
CompletedFirst Posted
Study publicly available on registry
August 16, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedDecember 11, 2020
December 1, 2020
1.9 years
August 15, 2011
December 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of mucosal healing changes by confocal laser endomicroscopy
Endomicroscopy will be used to assess the mucosal structure before and after treatment. Further Parameters: * assessment of mucosal barrier function in vivo during ongoing endoscopy * epithelial cell structure (development of new tools to differentiate mucosal structures and cells), e.g. crypt distortion, crypt lumen * infiltration of mononuclear cells * translocation of bacteria
1 year
Eligibility Criteria
trusted IBD diagnosis (Crohn's disease of ulcerative colitis)
You may qualify if:
- Indication for therapy with infliximab according to the current guidelines.
You may not qualify if:
- Inability to provide written informed consent
- Pregnancy or breast-feeding
- Severe uncontrolled coagulopathy
- Impaired renal function
- Known allergy to fluorescein
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Medicine I, University of Erlangen-Nuremberg
Erlangen, 91054, Germany
Related Publications (1)
Hundorfean G, Chiriac MT, Mihai S, Hartmann A, Mudter J, Neurath MF. Development and Validation of a Confocal Laser Endomicroscopy-Based Score for In Vivo Assessment of Mucosal Healing in Ulcerative Colitis Patients. Inflamm Bowel Dis. 2017 Dec 19;24(1):35-44. doi: 10.1093/ibd/izx012.
PMID: 29272480DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2011
First Posted
August 16, 2011
Study Start
May 1, 2011
Primary Completion
April 1, 2013
Study Completion
August 1, 2013
Last Updated
December 11, 2020
Record last verified: 2020-12