Antifungal drug may reshape gut bacteria for months

NCT ID NCT07295314

Knowledge-focused Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests how the antifungal drug fluconazole changes the gut microbiome and immune system in 50 healthy men aged 18-35. Participants take one pill daily for 14 days or receive no treatment. Researchers will compare stool and blood samples over 6 months to see if and how long the microbiome changes last.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: fluconazole (antifungal drug)
What this could lead to: If successful, this could help doctors understand how antifungal medications impact gut health and immune function.
What could go wrong: This is a very early, small study in healthy young men, so results may not apply to patients or predict long-term effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 35 years

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 compromise data interpretation

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Antifungal therapy Gut microbiome Healthy adult male

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

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Antifungal drug may reshape gut bacteria for months

What the study statuses mean