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

Phase 2

Terminated

• Conditions: Crohn's Disease Aggravated
• Interventions: Other: Placebo; Drug: Fluconazole

• Registration Number: NCT02997059
• Lead Sponsor: University Hospital, Lille

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Primary Completion: 2014-06
• Study Completion: 2015-06
• Status Verified: 2016-12
• Study First Submitted: 2016-12-14
• Study First Submitted QC: 2016-12-14
• Last Update Submitted: 2016-12-14
• Study First Posted: 2016-12-19
• Last Update Posted: 2016-12-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	One capsule per day for 6 months
Fluconazole	Fluconazole	200mg per day for 6 months

Primary Outcome Measures

Name	Time	Method
Rate of ASCA	6 months	the dosage of ASCA in the serum

Secondary Outcome Measures

Name	Time	Method
Appearance or not of a clinical recurrence assessed by Crohn Disease Activity Index (CDAI >=220)	6 months
Clinical recurrence : surgery for CD (except for proctological surgery)	6 months
Identification of yeast digestive colonization	during 6 months
Quantification of yeast digestive colonization	during 6 months
Endoscopic recurrence : Rutgeerts Score>1	6 months
Number of patients with adverse events as a measure of safety	during 6 months	Evaluate the clinical and biological safety of the daily dose of fluconazole in this population

Trial Locations

Locations (1)

CHRU, Hôpital Claude Huriez; 🇫🇷 Lille, France