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

NCT ID: NCT02997059

Last Updated: 2016-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2015-06-30

Brief Summary

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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

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Conditions

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Crohn's Disease Aggravated

Keywords

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Crohn disease Candida ASCA

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Fluconazole

200mg per day for 6 months

Group Type EXPERIMENTAL

Fluconazole

Intervention Type DRUG

200 mg/ day

Placebo

One capsule per day for 6 months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

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Fluconazole

200 mg/ day

Intervention Type DRUG

Placebo

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre Desreumaux, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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CHRU, Hôpital Claude Huriez

Lille, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 33922391 (View on PubMed)

Other Identifiers

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2008-000717-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PHRC2006R/1903

Identifier Type: OTHER

Identifier Source: secondary_id

2006_27

Identifier Type: -

Identifier Source: org_study_id