Status:

COMPLETED

Endomicroscopy in IBD Patients

Lead Sponsor:

University of Erlangen-Nürnberg Medical School

Collaborating Sponsors:

Merck Sharp & Dohme LLC

Conditions:

Crohn's Disease

Ulcerative Colitis

Eligibility:

All Genders

18-70 years

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 patie...

Detailed Description

The main goal of treatment for Crohn's disease and ulcerative colitis has always been the induction and maintenance of symptomatic improvement or at best remission. There is recent evidence that with ...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Indication for therapy with infliximab according to the current guidelines.
  • Exclusion criteria:
  • Inability to provide written informed consent
  • Pregnancy or breast-feeding
  • Severe uncontrolled coagulopathy
  • Impaired renal function
  • Known allergy to fluorescein

Exclusion

    Key Trial Info

    Start Date :

    May 1 2011

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    August 1 2013

    Estimated Enrollment :

    50 Patients enrolled

    Trial Details

    Trial ID

    NCT01417728

    Start Date

    May 1 2011

    End Date

    August 1 2013

    Last Update

    December 11 2020

    Active Locations (1)

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    1

    Department of Medicine I, University of Erlangen-Nuremberg

    Erlangen, Germany, 91054