MedTrace Logo

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

NCT07295314 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-12-19

No results posted yet for this study

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

DRUG

Fluconazole 200mg tab

Oral administration of one 200 mg fluconazole tablet once daily for 14 days.

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2027-10-31
Completion
2027-12-31

Countries

  • Netherlands

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07295314 on ClinicalTrials.gov