Clinical trial NCT02997059: Effect of Fluconazole on the Levels of ASCA After Surgical Resection for Crohn's Disease.
Official 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Crohn's Disease Aggravated
Keywords: Crohn disease
Candida
ASCA
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2016-12-19
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of ASCA
timeFrame: 6 months
Secondary outcomes:
measure: Identification of yeast digestive colonization
timeFrame: during 6 months
measure: Quantification of yeast digestive colonization
timeFrame: during 6 months
measure: Endoscopic recurrence : Rutgeerts Score>1
timeFrame: 6 months
measure: Clinical recurrence : surgery for CD (except for proctological surgery)
timeFrame: 6 months
measure: Appearance or not of a clinical recurrence assessed by Crohn Disease Activity Index (CDAI >=220)
timeFrame: 6 months
measure: Number of patients with adverse events as a measure of safety
timeFrame: during 6 months
Other outcomes:
Locations:
city: Lille
country: France
facility: CHRU, Hôpital Claude Huriez
Study officials:
affiliation: University Hospital, Lille
name: Pierre Desreumaux, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.