Trial document





This trial has been registered retrospectively.
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  DRKS00009235

Trial Description

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Title

Prospective, controlled, multicenter trial on the prognostic significance of video capsule endoscopy (Capsule Endoscopy) of the small intestine in ulcerative colitis

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Trial Acronym

CapColitis

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URL of the Trial

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Brief Summary in Lay Language

In the historic definition of ulcerative colitis the small intestine at UC is not infected, in contrast to Crohn's disease. These definitions were carried out with no particular sensitive diagnostic methods. In this study the small intestine of the UC patients should systematically be assessed with a highly sensitive method of analysis (video capsule endoscopy) and the course of the disease is observed. It is believed that even in UC patients small lesions in the small intestine can be found with a highly sensitive assay system which may could have potentially prognostic significance for the course of the desease and for the response of an anti-TNF alpha therapy.

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Brief Summary in Scientific Language

The genetic overlap of ulcerative colitis and Crohn's disease is approximately 50%. This corresponds to the clinical observation of a not rare phenotypic overlap of pathologies particularly in the long term course. Only a relatively small proportion of the UC patients respond to the TNF-alpha antibody therapy. Observations show that these patients with a genetic overlap for Crohn's disease also show more phenotypic CD aspects. In the historic definition of UC the small intestine is not infected, unlike the CD. These definitions were partly carried out with low sensitive diagnostic methods. In this study the small intestine of the CU patients should systematically be assessed with a highly sensitive method (video capsule endoscopy) and the desease will be prospectively observed in the long term. It is postulated that even in UC patients small intestine lesions could be asassed with a highly sensitive assay system that could potentially have prognostic significance for the course of the desease and for the response of an anti-TNF alpha therapy.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00009235
  •   2015/08/17
  •   [---]*
  •   yes
  •   Approved
  •   D745/12, Ethikkommission der Christian-Albrechts-Universität zu Kiel
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   K51 -  Ulcerative colitis
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Interventions/Observational Groups

  •   small intestine capsule endoscopy in patients with ulcerative colitis who were enrolled in the study BioColitis (DRKS00009219)
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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Incidence of pathological findings in the small intestine of CU patients using video capsule endoscopy (VCE).

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Secondary Outcome

1. predictors and prognostic significance of detectable intestinal changes
 2. characterization of factors influencing the natural history of UC
  3. Predictive significance of the small intestine changes to therapy need and the therapeutic effect of a TNF-alpha therapy
  4. proportion of UC patients with a complicated course (steroid dependency or refractary, proctocolectomy) with a detection of small bowel changes
  5. Genetic characterization of CU patients with and without changes in the small intestine using VCE

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2013/06/04
  •   300
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

Ulcerative colitis patients who were enrolled in the study BioColitis (Cu with an early history - enrollment <2 years after initial diagnosis or initiation of a TNF-alpha therapy)

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Exclusion Criteria

Age at inclusion of small 18 and larger 80 years

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Addresses

  • start of 1:1-Block address primary-sponsor
    • CED Service GmbH
    • Mr.  Klaus  Fitzke 
    • Hopfenstr. 60
    • 24103  Kiel
    • Germany
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    • Praxis
    • Mr.  PD Dr.  Bernd  Bokemeyer 
    • Uferstraße 3
    • 32423  Minden
    • Germany
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    • CED Service GmbH
    • Ms.  Karen  Schmidt 
    • Hopfenstraße 60
    • 24103  Kiel
    • Germany
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Sources of Monetary or Material Support

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    • CED Service GmbH
    • Mr.  Klaus  Fitzke 
    • Hopfenstr. 60
    • 24103  Kiel
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/02/28
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.