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Completed

NCT Number: NCT02997059

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

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.

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Key information

Conditions

Crohn's Disease Aggravated Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Torulopsis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHRU, Hôpital Claude Huriez

Lille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluconazole

Drug

200 mg/ day

Placebo

Other

Primary outcomes

  1. Rate of ASCA

    Time frame: 6 months

    the dosage of ASCA in the serum

Secondary outcomes

  1. Identification of yeast digestive colonization

    Time frame: during 6 months

  2. Quantification of yeast digestive colonization

    Time frame: during 6 months

  3. Endoscopic recurrence : Rutgeerts Score>1

    Time frame: 6 months

  4. Clinical recurrence : surgery for CD (except for proctological surgery)

    Time frame: 6 months

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

    Time frame: 6 months

  6. Number of patients with adverse events as a measure of safety

    Time frame: during 6 months

    Evaluate the clinical and biological safety of the daily dose of fluconazole in this population

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study 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

Acronym: AscaMC

Important dates

Study start
2008
Primary completion
2014
Study completion
2015
First posted
Dec 19, 2016
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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