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

Primary Purpose

Crohn's Disease Aggravated

Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Fluconazole
Placebo
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease Aggravated focused on measuring Crohn disease, Candida, ASCA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHRU, Hôpital Claude Huriez

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fluconazole

Placebo

Arm Description

200mg per day for 6 months

One capsule per day for 6 months

Outcomes

Primary Outcome Measures

Rate of ASCA
the dosage of ASCA in the serum

Secondary Outcome Measures

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

Full Information

First Posted
December 14, 2016
Last Updated
December 14, 2016
Sponsor
University Hospital, Lille
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT02997059
Brief Title
Effect of Fluconazole on the Levels of ASCA After Surgical Resection for Crohn's Disease.
Acronym
AscaMC
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

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Terminated
Why Stopped
Limited recourse to intestinal resection due to new management of CD
Study Start Date
July 2008 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
Ministry of Health, France

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease Aggravated
Keywords
Crohn disease, Candida, ASCA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fluconazole
Arm Type
Experimental
Arm Description
200mg per day for 6 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
One capsule per day for 6 months
Intervention Type
Drug
Intervention Name(s)
Fluconazole
Intervention Description
200 mg/ day
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Rate of ASCA
Description
the dosage of ASCA in the serum
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Identification of yeast digestive colonization
Time Frame
during 6 months
Title
Quantification of yeast digestive colonization
Time Frame
during 6 months
Title
Endoscopic recurrence : Rutgeerts Score>1
Time Frame
6 months
Title
Clinical recurrence : surgery for CD (except for proctological surgery)
Time Frame
6 months
Title
Appearance or not of a clinical recurrence assessed by Crohn Disease Activity Index (CDAI >=220)
Time Frame
6 months
Title
Number of patients with adverse events as a measure of safety
Description
Evaluate the clinical and biological safety of the daily dose of fluconazole in this population
Time Frame
during 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Crohn disease patients with a small intestine localisation (ileum or ileocecal) 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 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 Preoperative rate of ASCA> 70 arbitrary units (+/- 10%) Informed consent signed to be involved in the study Exclusion Criteria: Pregnant women or without adequate contraception Total length of the resection(s) of the small intestine more than 1 meter Subtotal colic resection Preoperative rate of ASCA<63 arbitrary units (+/- 10%) Known hypersensitivity to fluconazole or other azoles Known liver disease or transaminase levels >1.5 the normal rate Patient with renal failure Inability to read and sign the informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Desreumaux, MD, PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU, Hôpital Claude Huriez
City
Lille
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33922391
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.
Results Reference
derived

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

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