Effect of Fluconazole on the Levels of ASCA After Surgical Resection for Crohn's Disease.

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Fluconazole on the Levels of Anti-Saccharomyces Cerevisiae Antibodies (ASCA) After Surgical Resection for Crohn's Disease. Multicenter, Randomized, and Controlled in Two Parallel Groups Versus Placebo

Conditions
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Crohn's Disease Aggravated

Intervention / Treatment
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* Drug: Fluconazole
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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: (i) Total length of the resection(s) of the small intestine less than 100 cm (ii) Segmental colectomy leaving in place at least another colonic segment as the rectum 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 Known liver disease or transaminase levels >1.5 the normal rate Patient with renal failure Inability to read and sign the informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluconazole<br>200mg per day for 6 months | Drug: Fluconazole<br>* 200 mg/ day<br>|
| Placebo Comparator: Placebo<br>One capsule per day for 6 months | Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of ASCA | the dosage of ASCA in the serum | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of yeast digestive colonization |  | during 6 months | 
| Quantification of yeast digestive colonization |  | during 6 months | 
| Endoscopic recurrence : Rutgeerts Score>1 |  | 6 months | 
| Clinical recurrence : surgery for CD (except for proctological surgery) |  | 6 months | 
| Appearance or not of a clinical recurrence assessed by Crohn Disease Activity Index (CDAI >=220) |  | 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 | during 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn disease, Candida, ASCA