Crohn's Disease AggravatedPhase 2AscaMCNCT02997059
Effect of Fluconazole on the Levels of ASCA After Surgical Resection for Crohn's Disease.
A Phase 2 study testing Fluconazole in people with Crohn's Disease Aggravated, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease Aggravated
- What is being tested?
- Fluconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2008to Jun 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Crohn's Disease Aggravated
- Being tested
- Fluconazole, Placebo
- Keywords
- Crohn disease, Candida, ASCA
- Medical subject headings
- Crohn Disease, Torulopsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluconazoleDrug
200 mg/ day
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Fluconazole | Experimental | 200mg per day for 6 months Receives: Drug: Fluconazole |
| Placebo | Placebo comparator | One capsule per day for 6 months Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of ASCA
the dosage of ASCA in the serum
Measured: 6 months
Secondary outcomes (6)
Identification of yeast digestive colonization
Measured: during 6 months
Quantification of yeast digestive colonization
Measured: during 6 months
Endoscopic recurrence : Rutgeerts Score>1
Measured: 6 months
Clinical recurrence : surgery for CD (except for proctological surgery)
Measured: 6 months
Appearance or not of a clinical recurrence assessed by Crohn Disease Activity Index (CDAI >=220)
Measured: 6 months
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
Measured: during 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study startJul 2008
- Primary completionJun 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn's Disease AggravatedStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Pierre Desreumaux, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02997059
- Sponsor's protocol ID
- 2006_27
- Other IDs
- 2008-000717-30, PHRC2006R/1903, 2008
- Acronym
- AscaMC
- Status last verified
- Dec 2016
- First submitted
- 14 Dec 2016
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 33922391
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02997059
- Acronym / sponsor ID
- AscaMC / 2006_27
- Conditions
- Crohn's Disease Aggravated
- Keywords
- Crohn disease, Candida, ASCA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Jul 2008
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 19 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluconazole | Experimental | Drug: Fluconazole200mg per day for 6 months |
| Placebo | Placebo comparator | Other: PlaceboOne capsule per day for 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
- Preoperative rate of ASCA> 70 arbitrary units (+/- 10%)
- Informed consent signed to be involved in the study
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluconazole200 mg/ day | Drug | Fluconazole |
| Placebo | Other | Placebo |
Primary outcome
Rate of ASCA
Time frame: 6 months
the dosage of ASCA in the serum
6 secondary outcomes
Identification of yeast digestive colonization
Time frame: during 6 months
Quantification of yeast digestive colonization
Time frame: during 6 months
Endoscopic recurrence : Rutgeerts Score>1
Time frame: 6 months
Clinical recurrence : surgery for CD (except for proctological surgery)
Time frame: 6 months
Appearance or not of a clinical recurrence assessed by Crohn Disease Activity Index (CDAI >=220)
Time frame: 6 months
Number of patients with adverse events as a measure of safety
Time frame: during 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Results publication: PubMed 33922391Sendid 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.
- Individual participant dataSharing planned: No
Related trials for Crohn's Disease Aggravated
Not yet recruitingPhase 3
Ustekinumab and Upadacitinib for Induction and Maintenance Therapy in Patients With Refractory Crohn's Disease: A Multicenter, Randomized, Parallel-Controlled Study
Crohn's Disease Aggravated, Crohn's Disease in Remission
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Desreumaux, MD, PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluconazole in people with Crohn's Disease Aggravated, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of ASCA (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02997059, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.