NCT02997059

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2008

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 14, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 19, 2016

Completed
Last Updated

April 21, 2026

Status Verified

December 1, 2016

Enrollment Period

5.9 years

First QC Date

December 14, 2016

Last Update Submit

April 16, 2026

Conditions

Crohn's Disease Aggravated

Keywords

Crohn diseaseCandidaASCA

Outcome Measures

Primary Outcomes (1)

  • Rate of ASCA

    the dosage of ASCA in the serum

    6 months

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Fluconazole

EXPERIMENTAL

200mg per day for 6 months

Drug: Fluconazole

Placebo

PLACEBO COMPARATOR

One capsule per day for 6 months

Other: Placebo

Interventions

FluconazoleDRUG

200 mg/ day

Fluconazole
PlaceboOTHER
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Crohn disease patients with a small intestine localisation (ileum or ileocecal)
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU, Hôpital Claude Huriez

Lille, France

Location

Related Publications (1)

  • 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.

    PMID: 33922391RESULT

MeSH Terms

Conditions

Crohn DiseaseTorulopsis

Interventions

Fluconazole

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Pierre Desreumaux, MD, PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2016

First Posted

December 19, 2016

Study Start

July 1, 2008

Primary Completion

June 1, 2014

Study Completion

June 1, 2015

Last Updated

April 21, 2026

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)