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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by University of Zurich.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT01012726
First received: November 11, 2009
Last updated: June 24, 2010
Last verified: June 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Fistula closure [ Time Frame: 01.08.2009 - 31.07.2012 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: November 2009
Estimated Study Completion Date: July 2012
Estimated 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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01012726

Contacts
Contact: 01 Studienregister MasterAdmins +41 (0)44 255 11 11

Locations
Switzerland
Recruiting
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
Investigators
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
  More Information

No publications provided

Responsible Party: Prof. Dr. Dr. Gerhard Rogler, University Hospital Zurich
ClinicalTrials.gov Identifier: NCT01012726     History of Changes
Other Study ID Numbers: FIST-MC-09
Study First Received: November 11, 2009
Last Updated: June 24, 2010
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on April 15, 2014