Effect of Fluconazole on the Levels of ASCA After Surgical Resection for Crohn's Disease.
NCT02997059 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35
Last updated 2026-04-21
Summary
This was prospective study randomized in two controlled parallel groups verum versus placebo. The objectives were to assess the influence of antifungal treatment with Fluconazole (FCZ) on the rate of ASCA and endoscopic recurrence at 6 months. The rational was based on our previous research having established i) a link between intestinal inflammation and the opportunistic fungal pathogen C. albicans -a yeast colonizing the human digestive tract- ii) the demonstration that this yeast species could be at the origin of ASCA, a prominent serological marker of CD. It was therefore hypothesized that the FCZ could lower the rate of ASCA and/or reduce the occurrence of recurrences.
Conditions
- Crohn's Disease Aggravated
Interventions
- DRUG
-
Fluconazole
200 mg/ day
- OTHER
-
Placebo
Sponsors & Collaborators
-
Ministry of Health, France
collaborator OTHER_GOV -
University Hospital, Lille
lead OTHER
Principal Investigators
-
Pierre Desreumaux, MD, PhD · University Hospital, Lille
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-07-31
- Primary Completion
- 2014-06-30
- Completion
- 2015-06-30
Countries
- France
Study Locations
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