Effect of Fluconazole on the Levels of ASCA After Surgical Resection for Crohn's Disease. (NCT02997059) | Clinical Trial Compass
CompletedPhase 2
Effect of Fluconazole on the Levels of ASCA After Surgical Resection for Crohn's Disease.
France35 participantsStarted 2008-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Crohn disease patients with a small intestine localisation (ileum or ileocecal)
✓. Ileal or ileocecal resection in the month before inclusion (resection of all macroscopic lesions). If resection with temporary stoma, the patient may be included at the time of surgery to restore the continuity
✓. Patient with low risk of recurrence according to the following criteria:
✓. Preoperative rate of ASCA\> 70 arbitrary units (+/- 10%)
✓. Informed consent signed to be involved in the study
Exclusion criteria
✕. Pregnant women or without adequate contraception
✕. Total length of the resection(s) of the small intestine more than 1 meter
✕. Subtotal colic resection
✕. Preoperative rate of ASCA\<63 arbitrary units (+/- 10%)
✕. Known hypersensitivity to fluconazole or other azoles