Crohn's Disease Aggravated Clinical Trial
— AscaMCOfficial title:
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
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.
| Status | Terminated |
| Enrollment | 35 |
| Est. completion date | June 2015 |
| Est. primary completion date | June 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: 1. Crohn disease patients with a small intestine localisation (ileum or ileocecal) 2. 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 3. 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 4. Preoperative rate of ASCA> 70 arbitrary units (+/- 10%) 5. Informed consent signed to be involved in the study Exclusion Criteria: 1. Pregnant women or without adequate contraception 2. Total length of the resection(s) of the small intestine more than 1 meter 3. Subtotal colic resection 4. Preoperative rate of ASCA<63 arbitrary units (+/- 10%) 5. Known hypersensitivity to fluconazole or other azoles 6. Known liver disease or transaminase levels >1.5 the normal rate 7. Patient with renal failure 8. Inability to read and sign the informed consent |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | CHRU, Hôpital Claude Huriez | Lille |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Lille | Ministry of Health, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Rate of ASCA | the dosage of ASCA in the serum | 6 months | No |
| Secondary | Identification of yeast digestive colonization | during 6 months | No | |
| Secondary | Quantification of yeast digestive colonization | during 6 months | No | |
| Secondary | Endoscopic recurrence : Rutgeerts Score>1 | 6 months | No | |
| Secondary | Clinical recurrence : surgery for CD (except for proctological surgery) | 6 months | No | |
| Secondary | Appearance or not of a clinical recurrence assessed by Crohn Disease Activity Index (CDAI >=220) | 6 months | No | |
| Secondary | 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 | Yes |