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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 18, 2014