Crohn's Disease Aggravated
Conditions
Keywords
Crohn disease, Candida, ASCA
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.
Interventions
DRUGFluconazole
200 mg/ day
OTHERPlacebo
Sponsors
University Hospital, Lille
Ministry of Health, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of ASCA | 6 months | the dosage of ASCA in the serum |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Identification of yeast digestive colonization | during 6 months | — |
| Quantification of yeast digestive colonization | during 6 months | — |
| Endoscopic recurrence : Rutgeerts Score>1 | 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 | during 6 months | Evaluate the clinical and biological safety of the daily dose of fluconazole in this population |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORPierre Desreumaux, MD, PhD
University Hospital, Lille
Outcome results
None listed