Gut MicrobiomeEarly Phase 1FAMENCT07295314
Effect of Antifungals on the Intestinal Microbiome - a Randomized, Controlled, Proof-of-concept Trial
A Early Phase 1 study testing Fluconazole 200mg tab in people with Gut Microbiome and Healthy Adult Male, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Gut Microbiome, Healthy Adult Male, Antifungal Therapy
- What is being tested?
- Fluconazole 200mg tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2026to Dec 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 14Show fewer
- 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 compromise data interpretation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
Amsterdam UMC
Amsterdam, 1105 AZ
Duveke de Gaay Fortman, MD, +3120566 9111, p.d.e.degaayfortman@amsterdamumc.nl
Rebekka Bout, +31205669111, r.rebel@amsterdamumc.nl
About this study
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:
Read more
- 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.
- Conditions
- Gut Microbiome, Healthy Adult Male, Antifungal Therapy
- Being tested
- Fluconazole 200mg tab
- Keywords
- Fluconazole, Antifungal Drugs, Mycobiome, Bacteriome, Microbiota Diversity, Innate Immune Response, Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluconazole 200mg tabDrug
Oral administration of one 200 mg fluconazole tablet once daily for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Fluconazole | Experimental | Participants will receive oral fluconazole 200mg once daily for 14 days. Receives: Drug: Fluconazole 200mg tab |
| No Intervention | No intervention | Participants assigned to the control arm will not receive any treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of fluconazole on the intestinal microbiome
Difference in gut bacteriome and mycobiome composition, ⍺- and ß-diversity between adults treated with an antifungal (fluconazole) and no intervention directly after completion of antifungal treatment (t=14 days).
Measured: 14 days (end of treatment)
Secondary outcomes (3)
Gut microbiome and mycobiome composition at 6 months post-treatment
Differences in gut bacteriome and mycobiome composition, including α- and β diversity, between fluconazole and no-intervention arms and compared to baseline, 6 months after completion of fluconazole treatment.
Measured: 6 months post-treatment
Gut microbial functional profiles after fluconazole treatment
Differences in gut microbial functional profiles, including metabolic pathways and in vitro fecal microbial fermentation, between fluconazole and no-intervention arms
Measured: Baseline, 14 days, 4 weeks, and 6 months
Systemic innate immune responses after fluconazole treatment
Differences in host systemic innate immune response profiles between fluconazole and no-intervention arms at baseline, 14 days, 4 weeks, and 6 months. Responses will be assessed using ex vivo stimulation assays of peripheral blood mononuclear cells and neutrophils, and measurement of antifungal antibodies.
Measured: Baseline, 14 days, 4 weeks, and 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 2025
- Study startJan 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut MicrobiomeStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to receive fluconazole or no intervention in a parallel-group design.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, W. J. Wiersinga, MD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07295314
- Sponsor's protocol ID
- 2023.0143
- Acronym
- FAME
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Antifungals on the Intestinal Microbiome - a Randomized, Controlled, Proof-of-concept Trial
- ClinicalTrials.gov ID
- NCT07295314
- Acronym / sponsor ID
- FAME / 2023.0143
- Conditions
- Gut Microbiome, Healthy Adult Male, Antifungal Therapy
- Keywords
- Fluconazole, Antifungal Drugs, Mycobiome, Bacteriome, Microbiota Diversity, Innate Immune Response, Healthy Volunteers
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Jan 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 19 Dec 2025 (actual)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to receive fluconazole or no intervention in a parallel-group design.
| Arm | Type | Receives |
|---|---|---|
| Fluconazole | Experimental | Drug: Fluconazole 200mg tabParticipants will receive oral fluconazole 200mg once daily for 14 days. |
| No Intervention | No intervention | –Participants assigned to the control arm will not receive any treatment. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
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 |
|---|---|---|
| Fluconazole 200mg tabOral administration of one 200 mg fluconazole tablet once daily for 14 days. | Drug | Fluconazole |
Primary outcome
Effect of fluconazole on the intestinal microbiome
Time frame: 14 days (end of treatment)
Difference in gut bacteriome and mycobiome composition, ⍺- and ß-diversity between adults treated with an antifungal (fluconazole) and no intervention directly after completion of antifungal treatment (t=14 days).
3 secondary outcomes
Gut microbiome and mycobiome composition at 6 months post-treatment
Time frame: 6 months post-treatment
Gut microbial functional profiles after fluconazole treatment
Time frame: Baseline, 14 days, 4 weeks, and 6 months
Systemic innate immune responses after fluconazole treatment
Time frame: Baseline, 14 days, 4 weeks, and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Fluconazole 200mg tab in people with Gut Microbiome and Healthy Adult Male, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 4 inclusion and 14 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: opening soon, as of the sponsor's last update on 19 Dec 2025. 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 Netherlands. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of fluconazole on the intestinal microbiome (time frame: 14 days (end of treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2025.