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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
35
200 mg/ day
CHRU, Hôpital Claude Huriez
Lille, France
Rate of ASCA
the dosage of ASCA in the serum
Time frame: 6 months
Identification of yeast digestive colonization
Time frame: during 6 months
Quantification of yeast digestive colonization
Time frame: during 6 months
Endoscopic recurrence : Rutgeerts Score>1
Time frame: 6 months
Clinical recurrence : surgery for CD (except for proctological surgery)
Time frame: 6 months
Appearance or not of a clinical recurrence assessed by Crohn Disease Activity Index (CDAI >=220)
Time frame: 6 months
Number of patients with adverse events as a measure of safety
Evaluate the clinical and biological safety of the daily dose of fluconazole in this population
Time frame: during 6 months
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