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

Crohn's Disease Clinical Trial

Official title:

FIST-MC-09 Study About the Effect of Doxycycline and Acetylcystein in the Treatment of CD-associated Fistulae

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01012726
• Other study ID #: FIST-MC-09
• Status: Terminated
• Phase: N/A
• First received: November 11, 2009
• Last updated: December 3, 2014
• Start date: November 2009
• Est. completion date: July 2012

Study information

• Verified date: December 2014
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

The investigators will study whether local instillation of Doxycycline and Acetylcystein results in fistula closure in CD patients.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: July 2012
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion criteria:

• fistulizing CD

• CD < 6 months

• at least one insufficient fistula closure try

Exclusion criteria:

• CDAI > 200

• Abscesses

• CRP > 100

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gerhard Rogler

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fistula closure		01.08.2009 - 31.07.2012	No