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

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ClinicalTrials.gov Identifier: NCT01012726
Recruitment Status : Terminated (not enough patients enrolled)
First Posted : November 13, 2009
Last Update Posted : December 4, 2014
Sponsor:
Information provided by (Responsible Party):
Gerhard Rogler, University of Zurich

Study Description
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Brief Summary:
The investigators will study whether local instillation of Doxycycline and Acetylcystein results in fistula closure in CD patients.

Condition or disease Intervention/treatment Phase
Crohn's Disease Procedure: Colonoscopy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Study Start Date : November 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy Fistulas

Arms and Interventions
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Intervention Details:
  • Procedure: Colonoscopy
    During the colonoscopy, we instill Acetylcystein and Doxycyline into the fistula.

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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
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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
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Switzerland
Zurich, Switzerland
Sponsors and Collaborators
Gerhard Rogler
Investigators
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Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
More Information
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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 Posted: November 13, 2009    Key Record Dates
Last Update Posted: December 4, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
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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