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

• Sponsor: University Hospital, Lille (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02997059
• Collaborator: Ministry of Health, France (Other)
• Enrollment: 35
• Location: 1
• Arms: 2
• Duration (Months): 83
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Crohn's Disease Aggravated	Drug: Fluconazole; Other: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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 Start Date: Jul 1, 2008
• Actual Primary Completion Date: Jun 1, 2014
• Actual Study Completion Date: Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fluconazole 200mg per day for 6 months	Drug: Fluconazole; 200 mg/ day
Placebo Comparator: Placebo One capsule per day for 6 months	Other: Placebo

Outcome Measures

Primary Outcome Measures

1. Rate of ASCA [6 months]

   the dosage of ASCA in the serum

Secondary Outcome Measures

1. Identification of yeast digestive colonization [during 6 months]

2. Quantification of yeast digestive colonization [during 6 months]

3. Endoscopic recurrence : Rutgeerts Score>1 [6 months]

4. Clinical recurrence : surgery for CD (except for proctological surgery) [6 months]

5. Appearance or not of a clinical recurrence assessed by Crohn Disease Activity Index (CDAI >=220) [6 months]

6. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

1. Preoperative rate of ASCA> 70 arbitrary units (+/- 10%)

2. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHRU, Hôpital Claude Huriez	Lille		France

Sponsors and Collaborators

• University Hospital, Lille
• Ministry of Health, France

Investigators

• Principal Investigator: Pierre Desreumaux, MD, PhD, University Hospital, Lille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Lille
• ClinicalTrials.gov Identifier: NCT02997059
• Other Study ID Numbers: 2006_27; 2008-000717-30; PHRC2006R/1903
• First Posted: Dec 19, 2016
• Last Update Posted: Dec 19, 2016
• Last Verified: Dec 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by University Hospital, Lille: Crohn disease; Candida; ASCA
• Additional relevant MeSH terms: Crohn Disease; Fluconazole

Study Results

No Results Posted as of Dec 19, 2016