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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial looked at how fluconazole — an antifungal drug — affects ASCA levels after surgery for Crohn's disease, so could you explain what ASCA levels actually measure and why lowering them after a bowel resection might matter for my disease management?
2Since this was a Phase 2 trial that has now completed, has enough data been published or presented from it that you can tell me whether fluconazole showed any meaningful effect on ASCA levels, and what that might mean for someone in my situation?
3Fluconazole is an antifungal, which is not a typical Crohn's treatment — what would be the reasoning for considering an antifungal approach after surgical resection, and is there a specific type of patient this would be most relevant for?
4Given that this trial focused on patients who had already undergone surgical resection for Crohn's disease, would my own surgical history or disease history make this kind of approach worth discussing as part of my post-surgery care plan?
5Are there standard post-surgical treatments for Crohn's disease that are already well-established, and how would an approach like the one studied in this trial compare to or fit alongside those options?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.