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Study About the Effect of Doxycycline and Acetylcystein in the Treatment of CD-associated Fistulae

This study has been terminated.
(not enough patients enrolled)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01012726
First Posted: November 13, 2009
Last Update Posted: December 4, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gerhard Rogler, University of Zurich
  Purpose
The investigators will study whether local instillation of Doxycycline and Acetylcystein results in fistula closure in CD patients.

Condition Intervention
Crohn's Disease Procedure: Colonoscopy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: FIST-MC-09 Study About the Effect of Doxycycline and Acetylcystein in the Treatment of CD-associated Fistulae

Resource links provided by NLM:


Further study details as provided by Gerhard Rogler, University of Zurich:

Primary Outcome Measures:
  • Fistula closure [ Time Frame: 01.08.2009 - 31.07.2012 ]

Estimated Enrollment: 20
Study Start Date: November 2009
Study Completion Date: July 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Colonoscopy
    During the colonoscopy, we instill Acetylcystein and Doxycyline into the fistula.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • fistulizing CD
  • CD < 6 months
  • at least one insufficient fistula closure try

Exclusion criteria:

  • CDAI > 200
  • Abscesses
  • CRP > 100
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01012726


Locations
Switzerland
Zurich, Switzerland
Sponsors and Collaborators
Gerhard Rogler
Investigators
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
  More Information

Responsible Party: Gerhard Rogler, Prof. Dr. Dr. Gerhard Rogler, University of Zurich
ClinicalTrials.gov Identifier: NCT01012726     History of Changes
Other Study ID Numbers: FIST-MC-09
First Submitted: November 11, 2009
First Posted: November 13, 2009
Last Update Posted: December 4, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Crohn Disease
Fistula
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Pathological Conditions, Anatomical
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents