Effect of Antifungals on the Intestinal Microbiome - a Randomized, Controlled, Proof-of-concept T… (NCT07295314) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
Effect of Antifungals on the Intestinal Microbiome - a Randomized, Controlled, Proof-of-concept Trial
Netherlands50 participantsStarted 2026-01
Plain-language summary
The goal of this clinical trial is to learn how the antifungal drug fluconazole affects the gut microbiome and immune system in healthy volunteers.
The main questions it aims to answer are:
* Does fluconazole change the gut bacteriome and mycobiome composition after 14 days of treatment?
* How long do these changes last (4 weeks and 6 months after treatment)?
* Does fluconazole affect the body's immune responses, such as blood cell activity and antifungal antibodies?
Researchers will compare two groups: participants who take fluconazole for 14 days and participants who receive no intervention.
Participants will:
* Either take one fluconazole tablet (200 mg) daily for 14 days, or receive no treatment
* Provide stool samples and blood samples at several timepoints
* Return for follow-up visits up to 6 months after treatment
This study is conducted at Amsterdam UMC, location AMC, with a planned enrollment of 50 healthy male volunteers aged 18-35 years.
Who can participate
Age range
18 Years – 35 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male, 18-35 years of age at the time of signing informed consent
* Healthy, as determined by medical history and physical examination; minor clinical abnormalities allowed if not introducing additional risk or interfering with study procedures
* Capable of giving written informed consent and able to comply with study requirements
* Normal defecation pattern (≤3 times/day and ≥3 times/week)
Exclusion Criteria:
* Major illness in the past 3 months, or significant chronic medical illness deemed unfavorable for enrollment
* Past or current gastrointestinal disease that may influence the gut microbiota (including inflammatory bowel disease or medication-treated irritable bowel syndrome)
* History of immunodeficiency
* History of malignancy
* Alcohol intake \>3 units/day on average
* Known allergy to antifungal drugs
* Use of antibiotics (except topical) within the past 3 months
* Use of antifungals (except topical) within the past 3 months
* Planned prolonged travel (\>4 weeks) to tropical countries during the study period
* Receipt of an investigational product within 3 months prior to study day 0
* Use of prescription or non-prescription drugs, herbal or dietary supplements within 3 months (unless deemed safe by investigator)
* Difficulty with blood donation or poor venous access in either arm
* Donation of \>500 mL of blood in the past 3 months
* Any other condition or circumstance that, in the investigator's opinion, could be harmful to the subject or …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Effect of fluconazole on the intestinal microbiome
Timeframe: 14 days (end of treatment)
Trial details
NCT IDNCT07295314
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)