NCT07295314

Effect of Antifungals on the Intestinal Microbiome - a Randomized, Controlled, Proof-of-concept Trial

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: Male
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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.

Conditions

• Gut Microbiome
• Healthy Adult Male
• Antifungal Therapy

Interventions

Type	Name	Description
DRUG	Fluconazole 200mg tab	Oral administration of one 200 mg fluconazole tablet once daily for 14 days.

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-10-01
• Completion: 2027-12-01
• First posted: 2025-12-19
• Last updated: 2025-12-19

Locations

1 site across 1 country: Netherlands