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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-000717-30 | EudraCT Number | ||
| PHRC2006R/1903 | Other Identifier | PHRC number, DGOS |
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluconazole | Experimental | 200mg per day for 6 months |
|
| Placebo | Placebo Comparator | One capsule per day for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluconazole | Drug | 200 mg/ day |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of ASCA | the dosage of ASCA in the serum | 6 months |
| 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 |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre Desreumaux, MD, PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU, Hôpital Claude Huriez | Lille | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33922391 | Result | Sendid B, Salvetat N, Sarter H, Loridant S, Cunisse C, Francois N, Aijjou R, Gele P, Leroy J, Deplanque D, Jawhara S, Weissmann D, Desreumaux P, Gower-Rousseau C, Colombel JF, Poulain D. A Pilot Clinical Study on Post-Operative Recurrence Provides Biological Clues for a Role of Candida Yeasts and Fluconazole in Crohn's Disease. J Fungi (Basel). 2021 Apr 22;7(5):324. doi: 10.3390/jof7050324. |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| C536972 | Torulopsis |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D015725 | Fluconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Other |
|
| 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 |
| D007410 | Intestinal Diseases |