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

University Hospital, Lille

Status and phase: Terminated; Phase 2

Conditions: Crohn's Disease Aggravated

Treatments: Other: Placebo; Drug: Fluconazole

Study type: Interventional

Funder types: Other

Identifiers

NCT02997059

2008-000717-30 (EudraCT Number)

2006_27

PHRC2006R/1903 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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35 participants in 2 patient groups, including a placebo group

Fluconazole

Experimental group

Description:

200mg per day for 6 months

Treatment:

Drug: Fluconazole

Placebo

Placebo Comparator group

Description:

One capsule per day for 6 months

Treatment:

Other: Placebo